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. Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients-and your career. Global Study Manager (GSM) for our Indianapolis, IN Location - U.S Remote Based Position The Company - COVANCE As one of the world's largest and most comprehensive drug development services companies, Covance has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today. The Position The Global Study Manager must prove to be knowledgeable and experienced in project management techniques related to clinical trials. The Global Study Manager is responsible for key client deliverables including budget, risk, and milestone management. Global Study Managers must demonstrate leadership across the Covance study team, keeping a collaborative attitude and fostering excellent communication within the team. Global Study Manager must be able to combine a strong understanding of client protocol specifics and study feasibility, to ensure successful study management and provision of outstanding customer service. Responsibilities/Duties: Key contact for clients; Liaison between Clients, CRO, and Covance Displays leadership to ensure successful interactions between Covance study team members needed to provide seamless study delivery to the client. Provides project management oversight; focusing on key client deliverables through budget, risk, and milestone management. Facilitates communications between Client and extended Covance study team, including Study Design Lead and Regional Study Coordinator. Performs review of SOW to ensure quality implementation of client specifics and requirements. Manages a portfolio of global and local studies with varying complexity. Acts as an ambassador on behalf of the client within Covance CLS and across Covance business units; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements Demonstrates through appropriate self-organization the ability to manage conflicting priorities and to make difficult decisions Able to act efficiently in an environment with dynamic timelines and priorities Accountable for the implementation, monitoring and reporting of performance metrics Actively participates in Covance CLS development through continuous process improvement, quality and productivity Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients Demonstrates strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget Displays appropriate self-organization and ability to manage conflicting priorities Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date Comply with CCLS Global Project Management strategy Support a culture of continuous improvement, quality and productivity Other duties as assigned Education/Qualifications High School Diploma required University degree in a scientific field strongly preferred Experience 2 years related industry experience; project management experience in clinical trials would be a strong asset. Tell Us About Yourself Not ready to apply? Connect with us to join our talent community.
Overview Clinical Data Manager II - BioMarker Home-Based in the US or Canada Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements. As the study data lead; be accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team's output to ensure the highest delivery quality, while adjusting resource allocations accordingly. Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at study initiation meetings. Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress. Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary. Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts). Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion. Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study. Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training. Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed. Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations. Ensures service and quality meet agreed upon specifications per the DMP and scope of work Have input in writing, reviewing and updating SOPs and associated documents as required. Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate. Maintain accurate records of all work undertaken. Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved. Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate. Perform medical and medication coding Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget. Arrange internal or external meetings as appropriate. Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team. Actively promote Biometrics services to sponsors whenever possible. Performs other related duties as assigned by management Education/Qualifications University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Knowledge of drug development process Knowledge of effective clinical data management practices Fluent in English, both written and verbal In lieu of above requirement, approximately six years experience in related field (e.g. pharmaceutical, laboratory, data analysis) Experience Six years of combined early or late stage DM experience in DM with two years of direct sponsor management and two years of technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets. Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations. Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions. Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies. Time management skill and ability to adhere to project productivity metrics and timelines Ability to work in a team environment and collaborate with peers Good organizational ability, communication and interpersonal skills Team working skills and good collaborator skills Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events. Knowledge of medical terminology Knowledge of science or a scientific background is preferred. Good oral and written communication skills Tell Us About Yourself Not ready to apply? Connect with us to join our talent community.
Job Overview Act as the Lead Programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) and electronic submissions. If desired, may supervise less-experienced statistical programmers carrying out line management responsibilities. This would include Performance Management and Development activities, disciplinary procedures and administrative activities. Act as the Biometrics Project Manager for assigned projects. Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity. Review and interpret Statistical Analysis Plans and provide comments for assigned projects. Ensure quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with minimal supervision. Representing Statistical Programming at internal project team meetings, client meetings and audits. Contribute to proposal activities and client presentations providing time and cost estimates for statistical programming activities. Perf01m ongoing review of hours for assigned projects, ensure all issues are highlighted and resolved as quickly as possible and ensure all non-contract tasks are identified, tracked and included in change order forms. Provide ongoing supervision, advice and consultation to Lead Programmers and programming team to ensure timely and efficient completion of projects. Provide feedback to management on the development potential of staff to assist in staff development. Perform interviews for selection of potential candidates. Ensure that study documentation is maintained to the standard required according to processes and acceptable for audit. Provide input into assessments of resource requirements on regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project. Encourage and participate in the ongoing review of the processes used by the statistical Programming group to ensure processes are continually improved. Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines. Perform other duties as assigned by senior Statistical Programming staff Education/Qualifications BSc in a computing, life science, mathematical or Statistical subject. A high computing content is considered beneficial; however proven computing skills are most important. Alternative academic qualifications or experience are assessed to ensure equivalent background. Experience 8 years experience in provision of programming support for clinical trial management and reporting, or equivalent experience. Extensive experience and proven skills in the development and review of SAS programs within a clinical trials environment. Experience in the preparation and review of Statistical Analysis Plans, study set-up and review of study specific documents, e.g. CRF and data validation guidelines. Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management. Thorough knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and nonprogrammers alike. Ability to apply extensive technical expertise and has full knowledge of other related disciplines to provide Consultancy and advice on programming and wider related issues to other departments and disciplines. Excellent problem solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible. Self motivation and ability to work independently without appreciable direction. A willingness to make decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary. Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelines. Good interpersonal skills and the ability to communicate appropriately with all levels of staff throughout the organization and confidently with other disciplines and external clients. Ability to promote a good team working environment, providing the client with a high quality service while recognizing our business needs. A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them.