Clinical Operations Manager - Homebased in USA - Large Biotech - ASAP start date
Salary: 140,000 - 160,000 USD (depending on experience)
Start Date: ASAP / March 2022
Interviews from: 14th February 2022
Accountable for the management, support and direct supervision to Clinical Operations staff across multiple therapeutic areas. Provides training, consultation and oversees metric compliance.
Lead and support clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s), you will:
- Oversee the development of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs
- Oversee Strategic Partners, CROs, and other 3rd party vendors
- Mentor, coach, and train direct reports in applicable tasks, responsibilities and regulations.
- Identify individual training needs; ensure compliance with required training as well as the timely completion of training records.
- Discuss and plan career development with direct reports in an on-going manner; provide guidance and assistance wherever possible.
- Ensure the consistency and quality of direct report performance: measure and report on Key Performance Indicators (KPIs); communicate with direct reports' project team(s) regarding input on performance; ensure issues and results of discussions are escalated appropriately to Clinical Operations senior management; manage and resolve performance issues. Oversee Strategic Partners, CROs, and other 3rd party vendors
- The assigned clinical studies may be high complexity and high risk, e.g. multiple indications, data safety monitoring boards and endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments
- Provide operational expertise and strategic input for assigned clinical trials