Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
Requisition ID: 36438BR
Post:Clinical Project Manager
Job Category: Clinical Trial Management
Job Description :
Responsible for the operational and financial management of clinical trial planning and execution for assigned projects. Close collaboration with other members within Clinical Trial Management (CTM) and with various functional units of NNI as well as HQ.
BUDGET & CONTRACT COORDINATION:
Ensuring project budget is developed and managed in line with organizational expectation, including the development of appropriate site budgets.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned staff.
- Ensure that all personnel understand the priorities of the business, that they are focused on those priorities and that their level of accountability is understood and accepted within a matrix environment.
- Ensure that all team members understand and work towards corporate and department goals.
DEPARTMENTAL MANAGEMENT AND STAFF DEVELOPMENT:
- Active mentorship of CTM staff to build talent across the department.
- Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management of self and instill in all staff across CTM department.
- Implements and may participate in continuous improvement processes for function.
PROJECT MANAGEMENT AND STAFF DEVELOPMENT:
- May support and communicate functional, departmental or organizational initiatives.
- May support the identification of training gaps within function or assigned personnel, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures for the functional locally.
- Cross team membership, coordination and motivation of the region across NNI. Lead Clinical Trial Unit (CTU) meetings across CMR.
- Responsible for representing NNI at International Study Group Meetings with HQ.
- Accountable for all aspects of vendor management for assigned studies, responsible to drive them to complete their activities in accordance with any contracted terms.
- Accountable for all project timelines and deliverables. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for performance and ensures this is integrated into the overall plan for the monitoring management project deliverables in accordance with project plan.
- Accountable for leading the activities relating to the execution of the CTM Audit Management Plan for assigned studies.
- Accountable for the quality of the clinical trial execution in partnership with CTM Managers and the assigned Lead CRA.
- Accountable for the development of the study specific quality plan.
- Active leadership to local project teams.
- Development and finalization of the study communication plan.
- Ensure local protocol amendments are written and submitted in a timely manner in accordance with local expectations.
- Facilitate the review of protocols with CTM team members, ensure PRC submission is completed in line with departmental expectations.
- Oversee the development of the eCRF or CRF as appropriate.
- Oversee the feasibility process, development of the feasibility questionnaire through collaboration across CMR key stakeholders.
- Accountable the final determination of the study site list from the site selection process.
- Oversight of the label approval process.
- Prepare and provide input into materials for Investigator Meetings and Monitors Training Meetings.
- Prepare and work with meeting planning group and HQ to plan and execute the coordination of the Investigator Meetings.
- Responsible for ensuring that all data pertaining to study status is compiled and reported monthly as appropriate.
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