Plan and manage multiple or complex/partnership Clinical Research Program(s) across all functional areas, within budget and timelines. Represents clinical research function at Advisory Boards, interactions with Regulatory Agencies and for evaluation of business opportunities including due diligence.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Budgetary responsibility for cost center or clinical research program. Ensure development of accurate budgets, contract development and execution, payments and tracking of study, clinical evaluation, and/or risk management expenditure as directed by your manager.
- Management of personnel development, mentoring and effective delegation to direct reports to meet program goals.
- Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff. Accountable for strategy development and execution for specified clinical area.
- Effective coordination of all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.
- Anticipate potential problems within a clinical program and create contingency plans accordingly. Elevate potential changes in regulatory, risk management, quality systems and/or clinical environment to leadership. Will perform this job in a quality system environment.
- Manage performance management process for the team.
- Critical review of vendor proposals and contracts to include CRO agreements and medical writers to ensure program success. Financial approval of contracts and expenses at specified level.
- Prioritization across teams to ensure strategic goals/milestones within Clinical Research, are met.
Program/development strategy/direct line management and research matrix management
- Clinical development or affairs representative for worldwide project team. Daily interaction with director, project manager, directors in multiple cross-functional areas, including finance, R&D, and/or regulatory affairs.
- Manages internal organization/department within larger Clinical organization in a cross-functional environment.
- Responsible for setting direction, creating/managing budget, prioritization, staff management and development.
Bachelor’s degree in medical or scientific field, or equivalent combination of education and experience. Advanced degree is preferred.
Must have 10+ years of clinical experience and 6+ years of clinical management experience., or an equivalent combination of education and work experience. IDE, risk management, and/or clinical evaluationexperiencerequired. Management experience in otherclinical operations and/or regulatory affairs positions desirable. Global experiencepreferred.