Accountable for the management and development of In House CRAs or lead CRAs within the Site Management function and resource planning related to the administration of clinical trials in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Close collaboration with other members of the management team within the Site Management function.
Reports to the head of Site Management of Clinical Trial Management, (CTM). Accountable for participating and taking a leading role in multiple internal cross-functional relationships locally to ensure the effective delivery of all some functional and departmental milestones. May be responsible to ensure that NACMR is represented in global meetings or with specific initiatives. Reporting to this position are either Managers of In- House CRAs and In-House CRAs or Managers of Lead CRAs and Lead CRAs. Provides input into the strategy and direction for site 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:
- Ensures support for ensuring functional operating budget is managed in line with organizational expectations, including expense management for staff reporting into this role.
- Ensures that the Site Management departmental spend is within the % target of agreed annual budget.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Accountable for the coaching, development and growth leading directly to improvement of talents of the In House CRA or Lead CRA personnel to meet increasing levels of responsibility.
- Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within function.
- Ensures that all functional personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.
- Provides support for ensuring that all functional personnel understand the priorities of the business, that they are focused on those priorities, and that their level of accountability is understood and accepted.
FUNCTIONAL MANAGEMENT AND STAFF DEVELOPMENT:
- Accountable for the input, development, implementation, and potentially the execution of strategies employed by the function to meet corporate or local goals or directives.
- 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 self and instills it in all staff across CTM department.
- Actively participates in local, and potentially global, management teams.
- Assists with ensuring that quality of performance is in accordance with departmental expectations for function.
- Cross team membership, coordination and motivation of the In House CRA function, locally and globally.
- Direct supervision of management and other staff, including training, development, hiring, discipline, and terminations. Provides standardized goals and objectives to the function based on corporate and local BSC targets.
- Ensures that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
- Identifies training gaps within In House CRAs, Lead CRAs, ...cont.