Sr Manager Clinical Research
2 months ago
MAIN PURPOSE OF ROLE
Along with their leadership team, plans and manages multiple or complex/partnership cost center or Clinical Development Program(s) across all functional areas, within budget and timelines. Represents clinical development function at Advisories, interactions with Regulatory Agencies and for evaluation of business opportunities including due diligence. Responsible for leadership and development of staff.
MAIN RESPONSIBILITIES
- May have budgetary responsibility for cost center or clinical program.
- Ensure development of accurate study budgets, contract development and execution, payments and tracking of study expenditure.
- 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 leaders.
- Participates in 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 or clinical environment to leadership.
- Manage performance management process for the team.
- Critical review of vendor proposals and contracts to include CRO agreements to ensure program success.
- Financial approval of contracts and expenses at specified level.
- Prioritization across teams to ensure strategic goals/milestones within Clinical Development, are met.
- Program/development strategy/direct line management and research matrix management.
- Clinical operational representative for worldwide project team.
- Daily interaction with director, project manager, directors in multiple cross-functional areas, including finance.
- 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.
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QUALIFICATIONS
Education
- Bachelors Degree (± 16 years)
- In medical or scientific field desired. an equivalent combination of education and work experience
- Masters Degree (± 18 years) Preferred
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Experience/Background
- 6-8 years of direct clinical research experience with 4-6 years of clinical research management preferred. IDE clinical experience is highly preferred. Management experience in other clinical operations positions desirable. Global experience preferred.
- Recognized leader in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business
- Considered a Subject Matter Expert and key contributor to initiatives
- Leader and key contributor to initiatives and advancement of Clinical Development as an organization.
The base pay for this position is $109,300.00 â $218,700.00. In specific locations, the pay range may vary from the range posted.
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