Job Description
Position Overview
We are seeking an experienced Senior Manager of Clinical Operation to lead the planning, execution and oversight of clinical trials from pre-clinical to clinical stage. This role will manage day-to-day trial operations, ensuring compliance with global regulatory guidelines and GCP while collaborating with cross-functional teams in a fast-paced biotech environment.
Key Responsibilities
- Lead and manage the operational aspects of clinical trials from start-up through completion, including protocol development, site selection, enrollment, conduct, monitoring and close-out of global trials while ensuring adherence to timelines and budgets.
- Develop and manage clinical trial budgets, timelines, and resource plans.
- Review and approve clinical trial documentation such as protocols, ICFs, monitoring plans, and study reports.
- Manage CROs, vendors and clinical sites, focusing on CNS-specific challenges (e.g., patient recruitment, biomarker collection) to ensure high quality trial execution.
- Oversee risk-based monitoring (RBM) and ensure data quality for regulatory submissions.
- Partner with Medical, Regulatory and Data Management to optimize protocols and address operational hurdles.
- Support pre-clinical to clinical transition activities for CNS programs.
- Ensure trials comply with ICH-GCP, FDA, EMA, and NMPA requirements.
- Identify and implement process efficiencies to accelerate trial execution.
Qualifications
- Advanced degree in life sciences is highly preferred
- 8+ years in clinical operations (biotech/pharma), with CNS trials experiences is preferred
- Hands-on experience with global Phase I-III trials, including CRO/vendor oversight.
- Strong knowledge of FDA/EMA regulations and CNS-specific guidelines.
- Detail-oriented problem-solver with the ability to proactively identify and resolve issues that could impact trial timelines or quality (e.g., site delays, enrollment challenges and protocol deviations)
- Builds strong relationships with internal and external stakeholders to drive alignment and engagement.
- Ability to thrive in a dynamic biotech environment, anticipating risks and adjusting strategies as needed.