Clinical Trial Manager

About the role

The Clinical Trial Manager oversees and leads the day-to-day clinical trial activities, managing cross-functional and third-party vendor activities and deliverables.

Responsibilities

• Manage and lead clinical trial activities, including oversight of outsourced clinical studies, protocol review, and request for proposal defense.
• Oversee project timelines, study plans, and clinical data management processes.
• Collaborate with internal and external teams, including vendors and trial sites, to address potential issues and communicate effectively.
• Review and develop key study documents such as protocols, informed consent forms, and study plans.
• Ensure compliance with regulatory standards and sponsor requirements through ongoing review of data and documentation.
• Monitor and track patient recruitment and site performance using spreadsheets and web portals.
• Support IND updates, including annual updates and DSURs.

Requirements

• A minimum of a Bachelor’s degree in Life Sciences or equivalent.
• A minimum of ten years clinical operations experience.
• A minimum of three years of experience leading clinical trials from start-up to database lock.
• Experience with all three phases of clinical trials (start-up, treatment phase, and database lock).
• Experience with central laboratory oversight, including depth specification review.
• Knowledge of sample collection and analysis processes.
• Experience with data privacy and GDPR guidelines.
• Experience with independent management and oversight of CROs and vendors.
• Experience with double-blind and placebo-controlled studies.
• Experience in a small biotech organization with the ability to adapt and think creatively.
• Excellent attention to detail, accuracy, and strong analytical skills.
• Comprehensive knowledge of FDA and/or EMEA regulations, ICH guidelines, and GCPs.