Responsible for the management and development of Clinical Research Associates (CRAs) within assigned region in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for regional operational aspects of planning and management of monitoring performance in accordance with departmental productivity expectations. Close collaboration with other CRA managers and with various functional units of NNI. Accountable that the regional operating budget and operating margins to be managed in accordance with expectations, including expenses.
Reports to the Associate Director, Field Management within Clinical Trial Management (CTM). Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of all functional and departmental milestones. Reporting to this position are Clinical Research Associates (CRAs). Effectively manages to the direction and strategy for monitoring 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 regional operating budget is managed in line with organizational expectation, including expense management.
- Ensures that the Field Management (FM) departmental spend is within the % target of agreed annual budget.
COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:
- Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned region.
- Ensures that all regional personnel understand and work toward corporate, department and individual goals and that the measures of those goals are understood and accepted.
- Ensures that all regional personnel understand the priorities of the business, are focused on those priorities and that their level of accountability is understood and accepted.
- Responsible forthe coaching, development and growth leading directly to improvement of talents of the personnel within the assigned region to meet increasing levels of responsibility.
DEPARTMENTAL MANAGEMENT & 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 and instills in all staff across CTM department.
FUNCTIONAL MANAGEMENT & STAFF DEVELOPMENT:
- Accountable for the quality of CRA performance within assigned region, and responsible for the quality of CRA performance across the function.
- Active membership on local management teams.
- Cross team membership, coordination and motivation of the region across NNI.
- Implements, and may participate in, continuous improvement processes for function.
REGIONAL MANAGEMENT & STAFF DEVELOPMENT:
- Direct supervision of assigned regional staff, including training, development, hiring, discipline, and terminations for them and the function. Ensures that standardized goals and objectives are implemented on corporate and local BSC targets.
- May provide input, support and communicate regional or functional organization initiatives.
- May support the identification of training needs within function and the development of training materials to meet those needs. May provide training as required to improve core competency and skill set of the function or region.
- Responsible for ensuring proactive management of regional staff and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the head of FM as required based on impact at the core business.
- Provides guidance and oversight to less experienced staff on communication of such.
- Supports the implementation and execution of strategies employed by the regional staff to meet corporate or local goals or directives.
- Responsible for all timelines and effective resource deployment across the assigned region. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for monitoring performance for the assigned region, and ensures this is integrated into the overall plan for monitoring the management of functional and departmental CTM business deliverables plan.
- Responsible for delivery of the productivity metrics for the assigned region, especially for monitoring visit report completion within the assigned timeframes and to the expectations of CTM.
REGIONAL OPERATING BUDGET & RESOURCE ALLOCATION:
- Responsible for regional fiscal workload projections.
- Responsible for the assessment and allocation of resources for the region and reviews utilization data on a monthly basis to adjust and manage deployment proactively and effectively.
- Responsible for the coordination of CRA deployment, including integration within project teams, enabling clear understanding and action in relation to the CTM escalation pathway.
- Accountable for the compliance and quality of CATS reporting for direct reports.
- 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 is a clear understanding of expectations as a project team member from the function to ensure the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT, novoDOCs, EDC, and other related systems as per requirements.
- Responsible for maintaining focus, locally, for specific department activities within CMR priorities.
- Supports the implementation of cross departmental work, locally, and communications for assigned as per the clinical development plans.
- Supports the implementation of cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
- 40-50% overnight travel required.
- Home office based. Must live within 100 mile radius of Dallas, TX