FSP Manager Clinical Operations
About The Position
The Manager Clinical Admin oversees daily line management for an assigned clinical administration team and serves as a leadership and professional role model. The role provides coaching and development support, manages team resourcing and alignment, and ensures staff receive appropriate training and ongoing professional and technical development. The manager collaborates with clinical operations senior management and executive staff on strategic planning and business development as required, and works with the leadership team on resourcing needs. A primary focus is line and performance management, including escalation of performance concerns and training needs to support adherence to PPD SOPs and WPDs. The position leads clinical administration initiatives to improve process efficiency, consistency, and quality. It analyzes performance metrics, develops and implements procedures and training processes, and supports project-specific training and mentoring for research staff and new team members. Work is performed in an office and/or clinical environment and may involve travel to site locations, domestic travel, and rare international travel.
Requirements
- Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
- Significant clinical research experience comparable to 5+ years, including remote and clinical monitoring and experience across all phases of the study life cycle, including start-up, interim, and close-out.
- At least 1 year of leadership responsibility.
- Advanced knowledge of ICH GCP, applicable regulations, and PPD/client procedural documents.
- Advanced knowledge of clinical trial phases, particularly study start-up, maintenance, and close-out.
- Advanced skills in managing, motivating, and mentoring staff.
- Ability to analyze and manage the clinical administration portion of business development bids and contracts for multiple studies within specific divisions or offices.
- Strong knowledge of budgets, projects, and metrics.
- Ability to handle multiple tasks, meet rigorous timelines, and work effectively in stressful situations.
- Excellent organizational skills and strong attention to detail.
- Excellent communication and interpersonal skills.
- Ability to travel if required.
Nice To Haves
- An equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.
Responsibilities
- Lead day-to-day management of multiple clinical administration team members, providing direct coaching and development support.
- Oversee resourcing, alignment, training, and ongoing professional development for the assigned division or office.
- Implement Clinical Administration initiatives to improve process efficiency, consistency of execution, and quality of output.
- Analyze performance metrics and provide feedback to enhance individual and team performance.
- Develop and implement Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), as necessary.
- Develop and implement training processes for clinical administration and clinical staff.
- Implement project-specific training for research staff and mentor new team members, including other Clinical Managers.
- Collaborate with clinical operations senior management and executive staff on strategic planning and business development as required.
- Escalate performance concerns and training needs to support adherence to PPD SOPs and WPDs.
- Collaborate with the leadership team on resourcing needs.
- Perform other duties and projects assigned by PPD management.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
