Randstad Life Sciences Andover, MA, USA
Dec 10, 2018
job summary: The Protocol Operations Lead (POL), using project management and leadership skills, is responsible for the operational delivery of one or more non interventional studies from study concept through to reporting and studies close out, in alignment with agreed timelines, cost and quality goals through the matrix leadership of the Study Team(s). The POL may also contribute to audits/inspections as appropriate. The POL is the primary point of contact between the Business Unit (BU) (including Clinical and Outcomes) and Global Product Development (GPD) at the study level. The POL will oversee operational delivery, through an external vendor where the operational activities are fully outsourced. The POL leads the Study Team operations and project manages study deliverables through internal (within GPD, business unit and other platform lines) and external resources and is the primary point of contact and interface between these functional groups. The POL will be responsible for liaising with members of the project team, to include but not limited to: Clinician, Business Operations, Health Economics Outcomes Research (HEOR), Project Manager from the fully outsourced vendors, and other third party vendors as required. location: Andover, Massachusetts job type: Contract salary: $27.28 - 32.09 per hour work hours: 9 to 5 education: Bachelors responsibilities: The major duties and responsibilities will include but are not limited to: Lead Operational Delivery at the Study Level Team Leadership Establish and charter the team through interaction with Fully outsourced vendors, GPD and partner lines Lead the study team in achieving time, cost, quality, goals & milestones Develop and maintain positive team dynamics Facilitate and reach effective decisions (documentation of key decisions) Lead development and maintenance of study level plans where required Ensure execution against the monitoring plans (if applicable) Manage delivery of data/work products according to the vendor oversight plan Manage critical changes and/or variance in Financial forecast and schedule Scope and deliverables Lead the team in managing issues and problem solving Provide "Operational Review" updates/presentations to senior leadership as requested Demonstrate Leader Behaviors in motivating and supporting the study team Optimize Operational efficiency Manage Study Resources Ensure Operational Effectiveness Ensure effectiveness and team health Analyze and Manage Risks & Opportunities Lead the Study Team in: Inspection Readiness preparation and coordination (including relevant QC activities) Ensure studies are conducted in compliance with GPP, relevant SOPsand systems and regulatory requirements Identifying opportunities and risks in association with the vendor and the NI study team Preparing, maintaining and implementing action plans as required to mitigate risks Ensuring cross-functional awareness and buy-in to the risk/opportunities action plans Manage Information & Communications Provide high quality study information to support decision making Ensure study team and stakeholders are informed of progress against goals, major study risks/opportunities and corresponding contingency/mitigation plans Ensure issue escalation and appropriate resolution Oversight of deliverables from the fully outsourced vendor Ensures clarity on the required SOPs and training to be undertaken by the operational team Management of budget and spend vs projections/contracts (as applicable) Ensure delivery of data management activities including development of CRFs/eCRFs to the relevant data standards Ensure site selection, recruitment projections; patient identification and retention strategies are clearly defined. Ensure clarity of the TMF requirements Ensure compliance with relevant SOPs and Workplace Guidelines and are familiar with applicable systems and processes. Overseeing measures and metrics to ensure compliance to CT24 and relevant SOPs (i.e., CT27) qualifications: Minimum requirement: Bachelor's degree or equivalent in one of the disciplines related to life sciences, drug development, project management or business. Prior Experience Preferred Experience in managing fully-outsourced projects or vendor oversight Extensive clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing non interventional studies Leadership, project management, resource management, administrative and technical capabilities Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization. Knowledge of team development principles and successful implementation required. Technical Competencies Knowledge and success in managing multiple research projects. Knowledge of applicable processes associated with managing a project along with applicable systems/technologies Understands and has the ability to manage large and complex budget; history of staying on or under budget skills: Project Management, SOP, Clinical research Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. Company Description: Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to in-house, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and in-house locations in 40 countries. We are a company built on a deep network of expertise that crosses industries and geographies. We recognize that talent comes in different forms, that every business has its unique challenges and opportunities. And our recruiting experts are skilled at marrying talent and business-identifying the ideal professionals for an organization's culture and its teams, its needs and its goals.