Overview
The Senior Clinical Program Manager provides technical and team leadership for clinical development projects, ensuring integration across functions and successful attainment of program goals. The role may involve reporting to department and business leadership.
Responsibilities
1. Lead clinical project teams, including planning, scheduling, and technical support.
2. Manage clinical project planning, scope, milestones, resource allocation, and develop integrated project plans aligned with industry standards.
3. Conduct team status meetings, ensure deliverables, and manage changes within approved boundaries.
4. Identify and mitigate clinical program risks, assessing trends and developing strategies.
5. Coordinate resources, troubleshoot issues, and implement solutions.
6. Maintain accurate files and ensure compliance with design control and GCP standards.
7. Manage communication within teams and with executive management, incorporating input from various functions.
8. Oversee vendors supporting clinical projects, ensuring timely and correct deliverables.
9. Resolve team conflicts, foster a creative and professional environment.
10. Mentor and develop team members, providing indirect supervision to program managers.
11. Improve product development processes and procedures.
Key Relationships
* Engage with commercial, regulatory, medical, and other functions to support project execution.
* Interface with cross-functional groups to support organizational goals.
Qualifications
Minimum requirements include a Medical Technologist degree or BS in STEM, 8+ years in clinical project management, 4+ years managing teams, and relevant coursework in project management, research ethics, or related fields. Knowledge of GCP, FDA regulations, and medical device standards is essential.
Skills & Capabilities
* Leadership and team management
* Technical and analytical skills
* Problem solving and conflict management
* Project management proficiency
* Excellent communication skills
Travel up to 15% may be required. Interested candidates are encouraged to apply. Werfen is an Equal Opportunity Employer committed to diversity and inclusion.
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