Covance

Covance Madison, WI, USA
Jul 19, 2019
Full time
Job Overview The Client Services Content Manager is responsible for good stewardship of the client-facing response library (primarily used by the proposals and RFI manager teams), with the overall mission to support the global commercial organization by facilitating and writing responses that are consistent, compelling and award winning in terms of new business. The position requires core competencies in editing, writing, information management and collaborating with stakeholders from various groups to provide accurate/validated information and data about the company. Manages proactive, thoughtful stewardship of company-wide response library content and templates Writes content for Qvidian document types. Edits content provided by subject matter experts. Ensures that content reflects corporate branding and identity. Will own, establish and maintain content metadata to make library content easy to search, retrieve and use. Establishes and executes processes for content management, including accuracy in subject matter and compliance with corporate policies. Identifies and resolves issues around client inquiry requirements and Covance capabilities Maintains appropriate knowledge of the technical and regulatory environments Monitors and implements constructive feedback from the user base. Administers users and maintains application and content security. Coordinates with the IT department and Qvidian Business Application Manager to ensure any technical concerns are addressed. Contributes to assigned RFI/RFP process improvement projects and supports implementation as defined and assigned by management Performs quality control activities for peers and less experienced staff Education/Qualifications Bachelors degree in a scientific, business or related field (or equivalent work experience) is recommended. Experience Minimum of 7 years direct CRO/pharma or other business-related experience preferred Proficiency in Qvidian or other proposal library / automation systems Previous experience responding to RFIs, RFPs and RFQs preferred Excellent customer service skills, attention to detail and ability to be persistent while maintaining tact Editing / writing / story crafting skills, preferably with previous life sciences experience Demonstrated proficiency in MS Office (especially Word styles and templates) Demonstrated ability to plan, multi-task and prioritize Demonstrated teamwork, communication (written and verbal), and organizational skills Proven ability to work independently Knowledge of related software applications (i.e. SFDC, SharePoint) preferred Ability to work to deadlines Strong analytical skills Ability to communicate appropriately and effectively with clients and Covance senior management Positive attitude and sense of urgency Possesses a general knowledge of CROs; ability to work across Business Unit service-lines is preferred
Covance Durham, NC, USA
Jul 19, 2019
Full time
Job Overview Sr Principal Biostatistician, FSP permanent, salaried Remote from anywhere in the U.S. or Canada Are you ready to discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in patients' lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative work place, along with access to comprehensive benefits. Your work is meaningful, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning. Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move. We are seeking Sr Principal Biostatisticians to lead large global or other major projects, analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients including tracking project activities and project time management. The selected candidate will provide statistical input into other disciplines' activities and participate in interdepartmental processes; provide technical solutions and advice to staff and clients on statistical processes; supervise and train less experienced biostatisticians within project activities; and be responsible for the development of Statistical Analysis Plans including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and mockups. Additional responsibilities include:• Ensure mechanisms are in place to maintain flow of appropriate information between disciplines on project team.• Responsible for Biostatistics deliverables within assigned projects.• Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project.• Statistical analysis of clinical trial data and related decision making.• Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Covance signatories.• Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.• Provide statistical input into design/review of format of CRFs.• Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.• Determine documentation requirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.• Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.• SAS programming and related activities for the presentation and analysis of clinical trial data.• Contribute to review and amendment of departmental processes and supporting documentation.• Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.• Provide support for special committees, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding.• Contact with client across multiple disciplines.• Contribute to proposal activities and client presentations.• Represent the department during audits.• Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.• Perform other duties as requested by management. Experience Required• Seven years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 10 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject• Interpersonal and effective communication skills; cooperative, team-oriented and proactive• Self-motivation and able to motivate others.• The ability to work to tight deadlines while maintaining high standards.• SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis, SAS Macro language.• Ability to adhere to strict guidelines and codes of practice.• A good knowledge of the overall Clinical Trial process and of its application within Covance Clinical Development.• Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.• Ability to explain statistical concepts to non-statisticians. • Supervisory, project management and organizational skills.• A proactive approach to management of day-to-day activities and actions that may affect Covance as a business.• A professional approach at all times. Education Required• MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.) Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us. Education/Qualifications MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability. Experience Ten years of postgraduate experience in the application of statistics to clinical trials, preferably with at least one year of statistical project responsibility with a CRO. Interpersonal and effective communication skills. Cooperative, team-oriented and proactive. Self-motivation. Ability to motivate others. The ability to work to tight deadlines while maintaining high standards. SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis. Ability to adhere to strict guidelines and codes of practice. A good knowledge of the overall Clinical Trial process and of its application within Covance Clinical Development. Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials. Ability to explain statistical concepts to non-statisticians. Supervisory and organizational skills. A proactive approach to management of day-to-day activities and actions that may affect Covance as a business. A professional approach at all times.
Covance Indianapolis, IN, USA
Jul 19, 2019
Full time
Job Overview Looking for a Lead Scientist to join our growing Bioanlaytical team in Indianapolis, IN . Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work! The Role: The Principle Investigator performs activities related to technical leadership for routine studies in compliance with appropriate protocol, Standard Operating Procedures (SOPs) and regulatory agency guidelines. The successful candidate will support the analytical direction, the technical conduct of analysis, and the review, documentation, and reporting of results, in a timely, efficient, and quality manner. The Lead Scientist serves as the Responsible Scientist or Principal Investigator as appropriate to support scientific work for non-regulated and GxP regulated studies. Able to lead and direct scientific work to support external methods and projects. Serves as an SD, RS, CS, LS or PI for non-regulated, GLP regulated and GCP regulated studies as applicable Ensures client programs meet Covance, client, and regulatory requirements in order to meet defined milestones along the drug development pathway Proactively identifies and responds to circumstances that may affect study success Develops and reviews protocols and sample analysis plans. Reviews data with the method development team to ensure methods are ready for validation. Approves validation methods and reviews sample analysis methods. Independently reviews and approves raw data. Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur and appropriate corrective action was taken. Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met. Reviews and approves reports for scientific accuracy and completeness. Ensures on time delivery of high quality data and reports. Provides technical support as needed. Assists with efforts to troubleshoot and solve assay problems. Recognizes the functions of different teams within Covance and seeks guidance when appropriate. Participates in scientific investigations. Approves QA project specific inspections. Approves data archival. Serves as the scientific point of contact for the client. Works with the client to determine project requirements. Gives scientific directives to the study team. Identifies scientific issues or scope changes within the study. Communicates and monitors scientific expectations with scientific staff and clients. Proactively identifies ways to increase client satisfaction. Promotes quality within the study team. Provides a technical resource for less experienced team members. Actively promotes collaboration within and across groups. Provides appropriate coaching and recognition to team members. Promotes a positive impression of Covance internally and within the industry. Able to plan, prioritize, and manage workload for large and complex projects. Demonstrated ability to manage high volume study work for key clients. Takes accountability and demonstrates responsibility regarding scientific study conduct. Good knowledge of client requirements. Manages time effectively. Performs other related duties as assigned. Why People choose to work at Covance? At Covance, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. Education/Qualifications Masters (MS) degree in science or related field Experience may be substituted for education Experience 3-4 years of experience in the job discipline Excellent communication and interpersonal skills Proven ability to prioritize and manage time Excellent attention to detail Able to utilize word processing, database, spreadsheet, and specialized software Experience and skill with Watson, Nautilus, and Analyst preferred Knowledge of regulatory agency guidelines
Covance Greenfield, IN 46140, USA
Jul 19, 2019
Full time
Job Overview The Lead Scientist ensures that the studies are carried out to the required standards and that all work is conducted in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved. The Lead Scientist serves as the main point of contact for analysts and clients and ensures that client deadlines are met. They are also responsible for the efficient completion of analytical procedures within the Biopharmaceutical CMC Solutions. The Lead Scientist is the primary point of study control and has overall responsibility for the scientific technical and regulatory conduct of studies allocated to him/her as well as for the approval of study data, interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance Successful candidate will have experience with more than one of the following: Cell-based assays, Vaccines, Gene Products, Cell Products, Immunochemical techniques including ELISA, FLow Cytometry. The job role for the Lead Scientist at this level is gained through experience within the role but will still be carried out under the guidance, as necessary, of an experienced Lead Scientist. Direction of study types and volume of work will be assigned in accordance with the level of experience. Work closely with laboratory personnel to ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures to ensure that the study is performed to the required scientific and regulatory standards. Serve as an expert in a relevant field and design and troubleshoot assays and perform hands-on activities as needed. Design study protocols and write study reports to meet client and regulatory requirements. Provide in-depth and up to date knowledge of GxP regulations as applicable; coordinate and manage organisation of multi-site studies. Hold ongoing study meetings and provide client feedback to team. Be aware at all times of study status and anticipate problems that may affect timing, quality, etc. and work with operations taking appropriate action to resolve such problems and prioritise analysis for clients. Be responsible for on time delivery targets (protocols/results/reports). Constructively participate in departmental meetings, team meetings, scheduling etc. Ensure that all study communication is documented and maintained and carried out to meet client requirements. Proactively manage client and study changes to meet timelines and ensure all changes (timelines/costs etc) are captured and communicated to business development and project management. Provide in-depth knowledge of relevant assays, advise internal / external clients on standard and novel study designs, and be aware of new technology development in order to look ahead to new assays or implementation. Serve as a back-up Lead Scientist as assigned to support additional projects. Perform tasks in the day-to-day running of BioCMC Operations as necessary. Ensure accurate and prompt completion of study timesheets, leave records, sickness certificates and overtime and expense claims. Perform any other task as may be reasonably requested by the BioCMC Management Author and approve analytical methods as needed Technically review analytical data Approve GMP / non-GMP data reports, CofAs, etc Author and approve validation protocols Author and approve validation reports Approve validation protocols Approve validation reports Author and approve Stability protocols Author and approve Stability reports Author and approve other study protocol and report, e.g. characterization study Perform study related GMP investigations, LIR, DEV, etc Perform study related CAPAs Oversee development of novel assays Education/Qualifications Masters Degree with 7 years of relevant experience or a PhD with 2 years of relevant experience. Experience B .S. or M.S.with 7 years of relevant experiences or a PhD with 2 years of relevant experience. Relevant experience will have been gained in study directing within the department or within a similar role external to Covance. Years of experience in other professional roles. Other required work-related experiences. The Lead Scientist shows proficient computing skills, including word processing and use of spreadsheets (e.g. Word, Excel). Previous experience with statistical software, project management software, and sample management system is preferred. Experience with Covance internal system, such as eQA and CMS, is a plus The Lead Scientist should possess an in depth understanding of Health and Safety policies, Company Policies and Procedures, and GxPs. The post holder should be able to communicate effectively with other Covance employees, as well as external Clients and suppliers etc
Covance Indianapolis, IN, USA
Jul 19, 2019
Full time
Job Overview We have an exciting opportunity for a Method Development Staff Scientist to join our team in Indianapolis, IN. Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work! This role: Researches and develops bio-analytical methods for quantitation of pharmaceutical compounds in biological matrices using a variety of analytical techniques, and in a manner consistent with current regulatory expectations. The method development chemist supports multidisciplined studies, generates results, solve problems, and interpret data of a scientific nature. ESSENTIAL JOB DUTIES: Undertakes original research that includes developing and confirming highly sensitive, reliable assay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues. Performs complex analytical methods on biological matrices, often involving problem solving situations. Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in bioanalytical and mass spectrometry studies and accepts leadership role in developing scientific approaches. Acts as research scientist, in a team work setting, for technical direction on complex bioanalytical and mass spectrometry projects. Responds to unscheduled deadlines, client needs, crises, etc. without neglecting other duties. Produces reports for reliable, sensitive, and validated methods of analyses. Authors scientific papers which are published in peer reviewed journals. Participates in client visits. Contributes to long-range planning and technical policies of the department. Performs other related duties as assigned. Why People choose to work at Covance? At Covance, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. Education/Qualifications PhD in chemistry or Biology, or equivalent degree, with 0 to 2 years of related experience. Relevant experience may be substituted for education. Experience and knowledge of analytical instrumentation (eg -ELISA, MSD, Gyros). Proven track record of analytical method development. Skilled in conducting research, compiling data, data interpretation, and writing reports according to regulatory requirements. Skilled in performing scientific presentations and preparing scientific publications. Knowledge of laboratory automation software, system software (WATSON LIMS), and Microsoft applications. Effective oral and written communication skills. Experience Elisa, MSD 2-5 years developing methods to support regulated analysis.
Covance Salt Lake City, UT, USA
Jul 19, 2019
Full time
Job Overview We have an exciting opportunity for a Lead Scientist to join our BioAnalytical Team in Salt Lake City, Utah . Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work! The Role: Able to lead and direct scientific work to support external methods and projects. Ensures client programs meet Covance, client, and regulatory requirements. Develops and reviews protocols and sample analysis plans. Reviews data with the method development team to ensure methods are ready for validation. Approves validation methods and reviews sample analysis methods. Independenty reviews and approves raw data. Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met. Reviews and approves reports for scientific accuracy and completeness. Provides technical support as needed. Assists with efforts to troubleshoot and solve assay problems. Recognizes the functions of different teams within Covance and seeks guidance when appropriate. Participates in scientific investigations. Approves QA project specific inspections. Approves data archival. Serves as the scientific point of contact for the client. Works with the client to determine project requirements. Gives scientific directives to the study team. Identifies scientific issues or scope changes within the study. Communicates and monitors scientific expectations with scientific staff and clients. Proactively identifies ways to increase client satisfaction. Promotes quality within the study team. Provides a technical resource for less experienced team members. Actively promotes collaboration within and across groups. Provides appropriate coaching and recognition to team members. Promotes a positive impression of Covance internally and within the industry. Able to plan, prioritize, and manage workload for large and complex projects. Demonstrated ability to manage high volume study work for key clients. Takes accountability and demonstrates responsibility regarding scientific study conduct. Good knowledge of client requirements. Manages time effectively. Performs other related duties as assigned. Why People choose to work at Covance? At Covance, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. Education/Qualifications Masters (MS) degree in science or related field Experience may be substituted for education Experience 3-4 years of experience in the job discipline Excellent communication and interpersonal skills Proven ability to prioritize and manage time Excellent attention to detail Able to utilize word processing, database, spreadsheet, and specialized software Experience and skill with Watson, Nautilus, and Analyst preferred Knowledge of regulatory agency guidelines
Covance Madison, WI, USA
Jul 18, 2019
Full time
Job Overview Maintains own schedules for CPS PK and stand-alone PK studies. Liaise with the relevant bioanalytical departments over the transfer of clinical PK and PD data. Creates and maintains PK Analysis Plan (PKAP) under the supervision of the study Pharmacokineticist (PKist) and/or group manager. Conducts non-compartmental (NCA) PK analysis in accordance with the protocol, protocol amendments and/or PKAP under guidance from the study PKist or group manager. Prepares PK analysis methodology sections and compiles stand-alone PK report tables and figures under guidance from study PKist or group manager. Conducts non-compartmental analysis on clinical datasets for use in interim PK reports under guidance from the study PKist or group manager. Draft interim clinical PK reports, including Tables, Figures and Listings. Performs QC checking of analysis datasets and/or reports (text, tables and figures) for CPS and stand-alone PK studies to ensure accuracy and completeness. Reviews QA/QC report audits and Sponsor comments for CPS and stand-alone PK reports with the study PKist. Responds to and incorporates QA/QC findings and Sponsor comments into the final reports under guidance from study PKist or group manager. Proactively communicates and interacts with study team, other departments, and clients. Assists study PKist in communication and interaction with other departments and clients, as applicable. Participates in process improvement projects to increase the efficiency of daily/routine procedures and reporting methods. Archives clinical PK data in a timely manner. Any other duties as assigned by the group manager or Associate Director. Education/Qualifications Minimum Required: A Bachelor degree in a scientific discipline. Experience may be substituted for education. Excellent communication and interpersonal skills Experience Minimum Required: Ability to learn/utilize PK software (Phoenix WinNonlin), word processing software, database, spreadsheet, and other specialized software like SigmaPlot. At least one year of general experience in relevant scientific or clinical fields.
Covance Greenfield, IN 46140, USA
Jul 18, 2019
Full time
Job Overview We have a great opportunity for an Associate Study Coordinator in our Metabolism Department at our Greenfield Indiana location. Covance's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. In this role, you will assist the Study Director and Principal Investigator in providing and coordinator scientific and administrative support in the production of high quality, accurate and timely study reports in compliance with appropriate company standards, GLP (Good Laboratory Practices), GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved. You work will focus on the collection, preparation and distribution of information such as protocols, amendments, and study schedules Duties and Responsibilities: Drafts protocols, amendments, and study schedules as appropriate using study outline or client supplied information Reviews study compliance against protocol, SOP, and regulatory agency guidelines Prepares study schedules based on input from Study Director & Principal Investigator. Uploads information into databases and communicates work plan to laboratory personnel and support groups, as applicable Participates in and assists Study Director and & Principal Investigator with pre-initiation and other study related meetings as required Pro-actively communicates and interacts with study team to ensure key milestones are achieved Serves as the primary contact in communication and interaction with other departments and clients as applicable Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence. Assists Study Director & Principal Investigator in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines. Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups. Assists in interpreting and evaluating data for reports Participates in the peer review process for scientific reports Reviews QAU report audit sand client comments Responsible for and drives report production through finalization, including archiving of data as appropriate. Prepares for and participates in routine client visits. Learns to host routine client visits and interacts/communicates with client as necessary. Maintains an awareness of the financial status of ongoing studies, including work scope changes Education/Qualifications Relevant degree (ie Life Sciences) plus 2 years of appropriate experience; relevant experience may be substituted for academic qualifications Demonstrated knowledge of the reporting process. Ability to communicate verbally and in writing at all levels inside and outside the organization. Basic familiarity with Microsoft Office Suite, computer skills, commensurate with essential functions, including the ability to learn a validated system. Ability to work under specific time constraint. Experience Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers. Prefer candidates with laboratory experience or CRO research experience
Covance Durham, NC, USA
Jul 18, 2019
Full time
Job Overview Responsible for developing a best in class patient recruitment, retention, engagement and compliance center of excellence. To direct a team of patient recruitment professionals who will support the development of the Centre of Excellence strategy and tactical implementation of patient recruitment, engagement, retention and compliance strategies across a diverse study portfolio. This Director/Senior Director role will involve working with internal and external partners and is expected to leverage patient centric networks. This role provide an exciting and dynamic opportunity to scope the future of this Patient Recruitment and Engagement Centre of Excellence, one key component will be supporting the vision for the integration of the laboratory data into a unique service offering for future clinical opportunities. This position would suit an individual looking for the opportunity to seek challenges beyond the core remit. Individuals whom have Physician Referral Recruitment experience will be considered Essential Job Duties: Study Delivery Continually scan the environment for next in class solutions to improve patient recruitment and create novel capabilities and processes to implement these solutions Ensure Patient recruitment & retention services, capabilities and solutions are optimally deployed. Develop and ensure implementation of best in class strategies for clients in order to meet or exceed recruitment goals. Ensure strategies leverage best in industry capabilities that are tailored to specific study needs Build and oversee staff (as applicable) that are responsible for executing and managing patient recruitment activities for Clinical Studies with a focus on time, budget, quality and metrics Employ a lessons learned philosophy which is supported by analytics, innovative patient strategies to develop future recommendations for this Centre of Excellence. Relationships Partner with service providers and build robust service offerings and mutually beneficial relationships Stakeholder management, Vendors, Patient Groups and Networks, internal collaborations Support strategic marketing strategies to promote a Patient Centric service offering Act as a spokesperson for the Feasibility, Recruitment and Engagement function Proven ability to provide leadership and strategic direction as a Subject Matter Expert in the Patient Relations environment Resource Recruit, train and mange talent by developing goals and objectives aligned with the Company strategic vision and mission ensuring high standards of quality and performance. Education/Qualifications Recommended: University/College Degree (preferably Post graduate and Life Sciences) or certification in a related allied health profession (i.e. Nursing, medical or laboratory technology) from an appropriately accredited institution or equivalent education and experience Broad knowledge and understanding of global drug development and the clinical trial project management process, with a special emphasis on patient recruitment and retention Thorough and practical working knowledge of ICH-GCP Guidelines, including relevant international requirements/guidelines for the conduct of global clinical development programs An understanding of aspects surrounding business development (time and cost estimates, bid defense, contracts) Proven ability to understand and communicate corporate policies Through knowledge of time and cost estimate development and pricing strategies Preferred: Extensive experience in developing Patient Centric approaches supported by innovative techniques to support clients' needs. Detailed knowledge of CRO and/or Pharmaceutical environment Thorough knowledge of relevant Clinical Study Delivery procedures, including Standard Operating Procedures. Master or other advance degree. High level of business acumen. Experience Minimum Required: 10 years relevant clinical research experience to include a minimum of 5 years in a Patient Centric role or 8 years project management or Delivery. Minimum of 10 years relevant clinical research experience in Investigational site or relevant research institution, pharmaceutical, or biotech organization The ideal candidate will possess 10+ years' experience with increasing levels of responsibility in a clinical research environment
Covance Princeton, NJ, USA
Jul 18, 2019
Full time
Job Overview As a Mobile Application Developer on the Covance Informatics team, you will participate in the end-to-end design, development and release of mobile, IoT, and web-based products for the award winning Xcellerate® clinical trials informatics platform. Working in a highly collaborative and dynamic environment, you will help drive product innovation and work with internal and external engineering, data science, business and customer teams to prototype and launch capabilities and service offerings that will shape the future of healthcare. Key areas of focus include: 1) the integration and analysis of preclinical, clinical and health outcomes data to improve protocol design, clinical site selection, and patient enrollment; 2) the design of intuitive interfaces to enhance the efficiency and quality of clinical monitoring; 3) the development of mobile healthcare apps supporting site monitoring, patient recruitment, and virtual clinical trials; 4) collaboration with data engineers and data scientists to develop strategies for creating, maintaining and delivering best-in-class analytic solutions; and 5) planning, implementation and support of large-scale, cloud-based SaaS deployments. We seek smart, focused, passionate self-starters who bring energy, new ideas and practical experience to a fast-paced and dynamic team, are obsessed with delivering useful and elegant solutions, and care deeply about their customers and each other. Covance Inc., the drug development business of LabCorp®, is the world's most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®. Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move. Responsibilities Participate in the full-stack design and development of web and mobile based SaaS solutions for integrating, processing and visualizing data at scale. Participate in the full development cycle from product inception, research and prototyping to release in production. Work with a team of software engineers to write production quality code while implementing your own ideas. Provide support for the rollout of a commercial SaaS offering Establish and promote agile development principles and best practices for software development. Stay up-to-date on modern software development technology, tools, and processes Partner with internal and external clients to translate business needs into elegant and workable systems. Education/Qualifications BS/MS in engineering, computer science, informatics, or similar. Experience 3 years of web or mobile development experience, preferably full-stack, with a demonstrated history of success designing secure, performant, scalable, and reliable solutions 3 years hands-on experience with .NET/C#, Java, or similar languages Proficiency in JavaScript technologies, such as Type Script, Angular, and React Preferably hands on experience with mobile application development for iOS or Android Experience using RESTful web APIs and application security Hands-on database (Oracle, MS SQL Server or PostgreSQL) experience and SQL proficiency Experience with UI design principles, data visualization, and making apps work intuitively Strong knowledge of general algorithms, design patterns and good coding practices Deploying and managing web applications and services in AWS or Azure Experience with agile software development and the ability to rapidly iterate in a dynamic environment Exceptional attention to detail and ability to apply standards and processes Self-motivated, strong delivery focus, and ability to work well within a team environment Excellent oral, written, and interpersonal communications skills
Covance Durham, NC, USA
Jul 18, 2019
Full time
Job Overview Covance is seeking a Senior Director of Operational Strategy, Oncology which can be based anywhere in the United States for the right candidate. The ideal candidate is an experienced leader within a TA Centre of Excellence, and is expected to leverage their Research and Development experience from Target Product Profile generation to operational study execution to aid the delivery team to sustainably grow a portfolio of innovative and profitable business. This includes orchestrating through a cross functional team the design of effective and differentiated strategies for operational execution with clients and internal experts in a therapeutic area within the CDCS, Phase I-III business. Further this person is expected to proactively contribute to cross enterprise business opportunities, leveraging their expertise to aid the growth of the integrated Oncology business across Covance and Lab Corp. In this critical role, the Senior Director is expected to establish new and grow existing client relationships, and be seen as an industry leader internally by colleagues and peers and externally by the client base. Commercial Acumen Experience and Requirements: This person must have a strong background across pharmaceutical development, with the Research & Development know-how combined with an excellent understanding of the industry, market and clients' needs , to present Covance's medical and scientific capabilities to clients. Contributes significantly to the growth within the Therapeutic Area. He/She designs and develops winning trial strategies and integrated solutions that result in clear differentiation in the marketplace, higher win rate, and a more profitable portfolio of business in the TA Owns and internally advocates for client needs, expectations and satisfaction; identifies, develops and fosters new and existing client relationships at senior operational levels with clients, KOLs, Vendor Partners etc., in partnership with operational colleagues, guiding teams in delivering to and establish/maintain effective client relationships Leads high quality, strategically innovative price competitive end-to-end business development strategies, including RFI response, proposal development, bid defence preparation and He/She is ambassador of the Company and supports Covance's capability, visibility and position through development of appropriate publications and presentations at conferences, meetings and webinars etc. Leadership Engages with Covance's leadership to help driving and implementation of TA-specific initiatives which aim to improve performance of the business, including cross TA and functional integrated opportunities, to grow and expand the Therapeutic Helps to define and implement the TA vision and strategy; translates this into key initiatives and priorities; develops and delivers against TA operating plans & project plans; able to achieve results in a global, virtual and complex environment; tracks and measures progress. Partners with peers ensuring consistency (quality, standards, policies, processes and practices) across the portfolio in the TA and across TAs Leads by Example in building and sustaining a scalable organization; creates a forward looking culture of ownership and accountability; delegates for development and growth; identifies and sets up high performers for success; is self-aware and a Effectively leads and/or coordinates in a global, complex environment; sets clear expectations for colleagues; leverages experience to coach and mentor for success; consistently communicates and connects; fosters a continuous learning environment Attracts, selects, on-boards, develops and retains high performing talent; strengthens and deepens talent bench and succession; Subject Matter Expertise Contributes to the TA commercial and scientific leadership and direction, leveraging expertise from other functions as required to ensure the successful growth and differentiation in the global marketplace Ensures appropriate development and delivery of TA & program-specific training Participates in training opportunities to advance knowledge of TA, drug development, GCP etc. Education/Qualifications Bachelor's degree required. Advance degree, PhD and/or MBA preferred Experience 15 or more years of Research & development and clinical research experience (pharmaceutical or biotech and CRO), preferably including 3 or more years leading cross-functional full development programmes from concept inception to defining the operational strategy for delivery of the clinical trials in respective Therapeutic Area Broader level client relationships and business development experience Demonstrated vision, strategy and growth experience Financial acumen in understanding and effectively contributing to a competitive study or Programme strategy which is profitable.
Covance Gaithersburg, MD, USA
Jul 18, 2019
Full time
Job Overview Senior Associate - HEOR The Senior Associate provides support for HEOR-focused research projects including literature reviews, qualitative and quantitative data collection as well oversight of patient-centered assessments in clinical studies. The selected candidate will have an understanding of qualitative and quantitative research methods, ability to conduct qualitative data collection and familiarity with and all aspects of study implementation. Duties include: Assist with client-facing preparing proposals, protocols, study reports, written memos, client correspondence and presentations. Conducts and assists in literature reviews including data abstraction from published articles and other sources To support client studies, prepares IRB submissions and oversees site management and training Contributes to the development of Data Collection Tools and oversees data collection May meet with client to review work plans, schedule meetings, describe data sources, explain patterns Participates in the evaluation of client engagements to review the work plan, budget, consultant contributions, client responses, and the potential for future work. Oversees external vendors as required. Education/Qualifications Undergraduate degree in health sciences, public health, public policy or the social sciences. Advanced degree (Master's or PhD) preferred. The individual should possess strong communication, organization and analytical skills; Strong project management skills; Demonstrated ability to prioritize and manage workload and meet project deadlines; Abilities with software programs; Ability to work in a fast-paced, dynamic environment Experience At least 3 years' experience of successful research, project management, and/or consulting experience at a CRO, consulting firm, or software company dedicated to data collection in a clinical setting
Covance Gaithersburg, MD, USA
Jul 18, 2019
Full time
Job Overview Senior Associate - HEOR The Senior Associate provides support for HEOR-focused research projects including literature reviews, qualitative and quantitative data collection as well oversight of patient-centered assessments in clinical studies. The selected candidate will have an understanding of qualitative and quantitative research methods, ability to conduct qualitative data collection and familiarity with and all aspects of study implementation. Duties include: Assist with client-facing preparing proposals, protocols, study reports, written memos, client correspondence and presentations. Conducts and assists in literature reviews including data abstraction from published articles and other sources To support client studies, prepares IRB submissions and oversees site management and training Contributes to the development of Data Collection Tools and oversees data collection May meet with client to review work plans, schedule meetings, describe data sources, explain patterns Participates in the evaluation of client engagements to review the work plan, budget, consultant contributions, client responses, and the potential for future work. Oversees external vendors as required. Education/Qualifications Undergraduate degree in health sciences, public health, public policy or the social sciences. Advanced degree (Master's or PhD) preferred. The individual should possess strong communication, organization and analytical skills; Strong project management skills; Demonstrated ability to prioritize and manage workload and meet project deadlines; Abilities with software programs; Ability to work in a fast-paced, dynamic environment Experience At least 3 years' experience of successful research, project management, and/or consulting experience at a CRO, consulting firm, or software company dedicated to data collection in a clinical setting
Covance Indianapolis, IN, USA
Jul 18, 2019
Full time
Job Overview Get ready to redefine what's possible and discover your extraordinary potential at Covance. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning. Education/Qualifications Bachelor's degree required in related field or equivalent work experience Experience Minimum 4 years Applicable minimum years of experience in budget and/or text development, or an equivalent combination of education and CRO/pharma/other related experience to successfully perform the essential job duties Excellent customer service skills, attention to detail and ability to be persistent while maintaining tact Demonstrated computer skills - requires excellent MS Office experience (specifically Excel, Word, Outlook) Knowledge of proposal management software applications (e.g., Salesforce.com, Qvidian, Proposal Automation applications) is preferred Demonstrated text editing and writing skills (based on business unit and/or team expectations) Demonstrated ability to plan, multi-task and prioritize Demonstrated teamwork, communication (written and verbal), and organizational skills Proven ability to work independently Ability to work to deadlines Strong analytical skills Ability to communicate appropriately and effectively with internal stakeholders, clients and Covance senior management Positive attitude and sense of urgency Possesses an ability and willingness to work across Business Units Ability to work irregular and/or extended hours as needed to meet the client's proposal deadline.
Covance Madison, WI, USA
Jul 18, 2019
Full time
Job Overview You are a Recruitment Coordinator, Scheduler, or HR Assistant with a passion for driving a best-in-class Candidate Experience. You have built a toolset of skills from customer service and calendar management, to event coordination and problem-solving. You are ready to learn and grow your career in Talent Acquisition. You want to do the best work of your life, and you want it to matter.We are proactive, creative, results-oriented team looking to reinvent Talent Acquisition at Covance, and we want to talk to you about a career with purpose. At Covance, your bold ideas will help bring innovative medicines to market and advance modern healthcare. As an integral member of the Recruitment & Talent Advisors team, you will help shape candidates' initial perceptions of our hiring processes and our culture. You will partner with hiring teams to support the attraction of top talent, from first contact, screening and interview scheduling to requisition management and the selection and hire of new employees. You will develop rapport with people at levels and keep them informed throughout the hiring process, from first contact through offer. Top 3 Reasons you should join us: 1. Energizing purpose. Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.2. Exceptional people. We are building a team of Business Relationship Managers, Strategic Sourcing Recruiters, and Candidate Experience Coordinators to transform Talent Acquisition at Covance. You will learn from the most talented human resources minds, in an agile, supportive, and caring environment.3. Extraordinary potential. You will work on the most stimulating and challenging talent challenges, in a flexible work environment, with the training and career development that will help you thrive personally and professionally.Requirements:• Previous experience providing administrative support to senior leaders or a talent acquisition and recruiting team • Excellent time management, organizational skills and affinity for process refinement• Ability to build relationships with candidates, hiring managers, and business stakeholders• Strong calendar, scheduling, and finance support skills• Strong attention to detail, follow-up and commitment to accuracy• Ability to work independently, be proactive and problem-solve• Excellent written and verbal communication skills and presentation skills in English.• Familiarity with applicant tracking systems; experience with iCIMS a plus• Strong computer skills in Microsoft Office: Outlook (intermediate), Word (basic), Excel (intermediate), PowerPoint (intermediate) and PeopleSoft (basic)There is no better time to join Covance. Together, let's shape new possibilities for your career and improve the lives of patients around the world. Education/Qualifications Associate's degree or minimum of 2 years' equivalent coordination experience. Experience Previous experience providing administrative support to senior leaders or a talent acquisition and recruiting team • Excellent time management, organizational skills and affinity for process refinement• Ability to build relationships with candidates, hiring managers, and business stakeholders• Strong calendar, scheduling, and finance support skills• Strong attention to detail, follow-up and commitment to accuracy• Ability to work independently, be proactive and problem-solve• Excellent written and verbal communication skills and presentation skills in English.• Familiarity with applicant tracking systems; experience with iCIMS a plus• Strong computer skills in Microsoft Office: Outlook (intermediate), Word (basic), Excel (intermediate), PowerPoint (intermediate) and PeopleSoft (basic)
Covance Madison, WI, USA
Jul 18, 2019
Full time
Job Overview Come join our Covance Pharmacokinetics team while working from your home office. Key Responsibilities: Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK and PD analysis and study objectives. Supervision of less-experienced Pharmacokineticists within project activities. Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team. Perform QC/review of analysis. Responsible for development of PK Analysis Plans, to include methodology, definition of derived variables and data-handling rules. Responsible for PK and PD deliverables within assigned projects. Conduct non-compartmental PK and PD analyses as specified in the report and analysis plans. Conduct compartmental modeling/simulation of PK, PD and PK/PD data and provide interpretation of the results Responsible for PK and PD input to reports including Clinical Study Reports Provide PK and PD guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for PK and PD input to protocol. Independent peer review of PK and PD deliverables, e.g., protocols, Analysis Plans, PK reports, Clinical Study Reports. Contribute to review and amendment of departmental processes and supporting documentation. Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management. Conduct interim PK and PD analyses, interpret the data and attend dose escalation teleconferences to support dose progression in allocated studies. Contact with client across multiple disciplines. Contribute to proposal activities and client presentations. Represent the department during project-driven client audits. Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP. Perform other duties as requested by management. Education/Qualifications Minimum Required: Bioanalytical Chemistry or a Biological Life Sciences Degree Experience Minimum Required: 5 years of postgraduate experience in the application of PK and PD to clinical trials for employees with a BSc in the field of Bioanalytical Chemistry or a Biological Life Sciences Degree. Proficient in compartmental /non-compartmental data analysis Specialist in WinNonLin Effective interpersonal and communication skills. Cooperative, team-oriented and proactive. Self-motivation. The ability to work to tight deadlines while maintaining high standards. Ability to adhere to strict guidelines and codes of practice. A good knowledge of Clinical Development. Competence in the preparation of Pharmacokinetic Analysis Plans, analysis, reporting, etc., across a variety of trials. Ability to explain PK and PD concepts to non-pharmacokineticists. An evident appreciation of the possible impact of day-to-day activities and actions on Covance as a business. A professional approach at all times.
Covance Dallas, TX, USA
Jul 18, 2019
Full time
Job Overview Responsible for ensuring that all practical aspects of clinical studies are conducted to the highest possible quality and in accordance with the protocol, SOPs and ICH/GCP standards. Provides leadership, training, coaching and mentoring for study staff. Duties and Responsibilities: Directly supervises staff which may consist of RNs, LVN/LPNs, and Research Technicians. Current knowledge of ICH/GCP standards. Demonstrate ability to lead by example and to encourage team members to seek solutions. Ensure that the safety, welfare and dignity of research subjects are not compromised. Ensure the quality of service provided by team members meets the requirements of both internal and external clients. Instill in all team members responsible to him/her the Company's commitment to quality and meeting the client's requirement without error, on time, every time. Play an active role in the development and implementation of Quality within his/her area of responsibility. Assist with the coordination of relevant protocols. Ensure that appropriate training programs are in place so that all personnel under his/her supervision are adequately and properly trained for their job requirements. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP. Ensure all work in his/her area is carried out in strict accordance with relevant protocols, SOPs, and in compliance with ICH/GCP. Ensures that the CRF product meets the customer expectations. Assist with planning of study set up, as needed. Ensure that the staff under his/her supervision area at all times adequate in quality and quantity to meet the agreed forecasted workload. Recommend changes if necessary and justify them in accordance with company policy. Ensure that a safe working environment is maintained and that safe working practices are employed. Ensure that good communications with both internal and external clients are maintained. Plan and schedule training inservices for his/her staff. Ensure that full and accurate data records are maintained. Keep management up to date on all aspects of his/her job and initiate improvements. Manage his/her area so as to meet the budgeted standard of performance. Respond constructively to management and QA ensuring that any GCP/ICH deficiencies are followed up with prompt remedial action. Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharge of operations staff. Coaches and mentors staff. Initiates, plans and implements appropriate staff development programs. Ensures that up to date manuals of SOPs and Policy and Procedures are available to all personnel in his/her work area. Performs Project Management duties/responsibilities in the absence of team Study/Project Manager. Acts as Study Manager for straightforward/uncomplicated Phase I protocols, under supervision of a designated supervisor. Has demonstrated the ability to assist Study/Project Manager with all aspects of monitor visits. Schedules investigators for protocol-related tasks. Updates or creates SOPs/P&Ps germane to their area of expertise. Schedules staff as appropriate for clinic requirements. Complies with departmental meeting schedules. Assists, as necessary, with study procedures. Tracks and evaluates Interdepartmental Monthly Key Result Indicators. Works on a wide range of opportunities and problems where use of creative thinking and the application of related quality and continuous improvement theories and principles is required. Continuously seeks out new and better ideas, driving best practices. Education/Qualifications BS in science or medical field CCRC/CCRP Experience 3-4 years research experience Minimum of 2 years supervisory experience
Covance Madison, WI, USA
Jul 18, 2019
Full time
Job Overview The Senior Project Coordinator is a great opportunity to gain the experience needed to lead into a Project Manager role. A few of the key responsibilities will be: Independently owns, creates and maintains study specific documents (e.g., Project Management Plan, Communication Plan, Risk Register, Project Specific Training Matrix and any other applicable plans as required), including compliance with client-specific requirements, for studies of varying complexity including external site studies. Distributes them to the study team and/or sponsor for review, compiles comments, and routes final documents. Independently monitors training compliance of the study team and updates the training matrix as required. Maintains an internal standardized filing structure for study related documents; proactively maintains documents within the filing structure, and suggests changes as necessary to maintain organized files. Independently uses and develops trial management tools to monitor study activity and perform tasks, including project setup activities (e.g., study ID request, SAS Environment Setup request, Study-specific Distribution Lists, etc.). Manages the setup and updating of CTMS; maintains knowledge and project expertise for CTMS reporting, study metrics, risk management regarding communication, coordination and eTMF quality. Makes timeline updates (key milestones, resources, study information) as required for the project. Oversees training and mentoring of other PCs; independently trains/mentors any department staff, including PMs, on tasks/processes/areas in areas of expertise; responsible for routine development/review/revision of PC training materials; maintains subject matter expertise in all aspects of the TMF. Coordinates and manages support across large global studies. Drives efficiency and quality in coordination activities and applicability to clinical trial management. Assists the PM or mentors an associate PC or PC in the setup of site regulatory binders (site master file including pharmacy file if required). Acts as the primary point of contact for external sites during study maintenance, responding to queries, providing documents. May maintain revenue recognition and metric information for stand-alone/single-service Biometrics projects, with oversight from a PM. May perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for Project Coordinators. Performs other duties as assigned. Education/Qualifications University/college degree, preferably in a healthcare/scientific field. Specific clinical research experience may be substituted for education. Experience 3-4 years of experience in a research environment. 2-3 years of experience working in a project management environment. Knowledge of protocol designs, study objectives, study procedures, and project-related timelines. Advanced knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines.
Covance Princeton, NJ, USA
Jul 18, 2019
Full time
Job Overview Looking for a Toxicologist to join our growing Safety Assessment team in Somerset, NJ . Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work! The Toxicologist is a part of a department that is directly responsible for the oversight and management of nonclinical studies supporting the drug development process. We are committed to providing our customers with exactly what they need, from single studies to managing complex programs to development of long term strategic partnerships. Manage the design, interpretation and reporting of in vivo non-GLP and GLP nonclinical toxicology studies, in collaboration with study monitors and other scientists Ensure timely and accurate communication of study results and interpretation those results to appropriate internal and external teams Ensure appropriate quality of documentation, writing, and editing of nonclinical sections of reports for regulatory submissions Develop relationships with key scientific collaborators (internal and external) Participate in departmental or company initiatives Promote the scientific reputation of the company through active participation in industry and interactions with peers Education/Qualifications PhD in Toxicology, Pharmacology, or other Biological Science required (or Bachelors/Masters with equivalent experience) DABT Certification a plus Experience Familiarity with nonclinical safety/toxicology safety assessment desirable Excellent organizational and prioritization skills Excellent verbal and written communication skills Ability to collaborate across departments
Covance Madison, WI, USA
Jul 18, 2019
Full time
Job Overview Responsible for performing practical/administrative activities of clinical trials in Clinical Pharmacology in line with protocol and regulatory requirements. Duties and Responsibilities: Accurately perform blood pressure, pulse, weights, respiratory rate and temperature readings Preparation and accurate recording of ECGs/Holters Collection and processing of biological samples as specified in the protocol and ensures the proper distribution of those samples. Monitors meals to ensure dietary compliance by research participants Assist with screening procedures as necessary Assist in the preparation of rooms and medical equipment Maintain a clean, safe and efficient working and study environment Transcription of data from source documentation onto the Case Report Forms (CRFs) for simple to complex studies and QC of CRFs. Foster respectful relationships with study participants Accurately record all research data obtained or observed Assist with training of new staff members Observe study subjects for general well-being and report appropriately. Assist with QC of source documents and case report forms Maintains a basic understanding of current regulatory requirements Attends all required meetings, as appropriate. Assists, as necessary, with study procedures. Maintains accurate records of all work undertaken. Maintains skills to perform all study tasks, as required Maintains constant awareness of participant safety and dignity at all times. Handles participant complaints efficiently and effectively in order that their satisfaction is maintained. Ensures that client and participant confidentiality is maintained. Responds to client and team queries in a timely manner. Takes ownership for the quality and standard of own work. Other duties as assigned Principal Contacts: Internal: Operational Staff, Supervisors, Managers, Physicians External: Study Participants Travel Requirements: Potential travel for cross-site support needs or training needs. Education/Qualifications Required: USA BS degree in related field Experience Required: USA Associates degree in related field and 1 year of clinical research experience may be substituted for BS degree High School diploma or equivalent and 1-2 years as a Clinical Research Technician I may be substituted for BS degree Proficient with computer programs