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.
Reports to the Senior Manager or Associate Director of Portfolio Management within Clinical Trial Management (CTM). Accountable for actively leading internal cross-functional teams locally to ensure the effective delivery of all project milestones. Effectively manages to the direction and strategy for performance within clinical trials at NNI thereby facilitating the CTM department to effectively manage all its business deliverables. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.
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.
- Approves vacation requests, meeting attendance, expense reports and check requests for staff.
- Accountable for the compliance and quality of CATS reporting for assigned personnel.
- May support the implementation cross departmental work, locally, and communications for assigned as per the clinical development plans.
- May support the implementation of work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
- Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations and that there clear understanding of expectations as a project team member from the function to ensure to the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
Responsible for maintaining focus, locally, for specific department activities within CMR priorities.
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support to needs across CTM and direct the creation, development and potentially provide training support to meet those needs.
- Approximately 20-30% overnight travel.
- Office Based - Princeton, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree required (scientific discipline preferred).
- A minimum of 7 years of clinical trial experience within pharmaceutical, biotechnology or CRO and/or healthcare setting, i.e., managing the logistics of clinical trial conduct and developing/executing project plans for clinical development programs.
- A minimum of 12 months on site monitoring or related equivalent experience required.
- Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Experience in international trial management preferred.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - PROJECT MGMT (1c)
Position Location US - Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%
Nearest Major Market: New Jersey
Job Segments: Clinic, Project Manager, Medical, Biotech, Manager, Healthcare, Technology, Science, Management