CSL - King of Prussia, PA
posted 3 months ago
Full-time - Senior
Hybrid - King of Prussia, PA
10,001+ employees
Ambulatory Health Care Services
About the position
The Lead Clinical Oversight Manager at CSL Behring is responsible for providing leadership and management of clinical programs within designated Therapeutic Areas (TAs). This role involves overseeing all clinical program deliverables, ensuring compliance with regulatory standards, and managing budgets and resources effectively. The position is hybrid and reports to the Regional Head of Site Partnerships, contributing to the development and delivery of lifesaving therapies for serious medical conditions.
Responsibilities
- Provide leadership and management of a clinical program in a designated Therapeutic Area (TA).
- Accountable for all clinical program or functional deliverables including Study Operations, Business Operations, and Compliance.
- Ensure activities supporting the TA model are planned according to strategy, regulatory standards, and within budget and timeframe.
- Negotiate CDAs, contractual terms, rate cards, and other contractual items with vendors supporting the TA model.
- Guide ownership of all deliverables through oversight and governance of vendors.
- Manage overall forecasts, budgets, and resource allocation in collaboration with clinical teams.
- Develop processes and standards to ensure inspection readiness of all clinical studies and compliance with quality standards.
- Manage internal quality processes to ensure quality is integrated into study activities.
Requirements
- Bachelor's degree in a Science-related discipline or equivalent.
- 7+ years of experience in a Clinical Operations environment.
- Global Clinical Operations experience is important.
- 2 years of on-site monitoring and clinical research experience or education.
- Knowledge of clinical trial systems and ICH GCP.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k)
- Paid time off
