FSP Manager Clinical Operations

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Manager Clinical Admin oversees daily line management for assigned clinical administration staff and serves as a positive leadership and professional role model. The role provides direct coaching and development support, and is responsible for effective resourcing, alignment, training, and ongoing professional and technical development of the team. The manager collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. The primary focus is line and performance management, including escalating performance concerns and training needs to support adherence to PPD SOPs and WPDs, and working with the leadership team to address resourcing needs. The role also oversees clinical administration initiatives to promote efficient processes, consistent execution, and quality output. It analyzes performance metrics, develops and implements WPDs, SOPs, and training processes, and supports project-specific training and mentoring for research staff, including new team members and other Clinical Managers. Other duties and projects may be assigned by PPD management.

Requirements

  • Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
  • Significant clinical research experience comparable to 5 or more years, including remote and clinical monitoring and experience in all phases of the study life cycle: 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 all phases of clinical trials, 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 manage 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.
  • An appropriate combination of education, training, and/or directly related experience may be accepted as equivalent in some cases.

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.
  • Ensure Clinical Administration initiatives are implemented to support efficient processes, consistent execution, and quality 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, including mentoring new team members and other Clinical Managers.
  • Collaborate with clinical operations senior management, executive staff, and the leadership team on strategic planning, business development, and resourcing as required.
  • Escalate performance concerns and training needs to help ensure adherence to PPD SOPs and WPDs.
  • Perform other duties and projects as assigned by PPD management.

Benefits

  • Opportunity to work as part of a global team.
  • Collaborative environment with development opportunities.
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