Senior Clinical Trial Manager

The role

The Senior Clinical Trial Manager will lead the startup, execution, and closeout of clinical studies for the COPD program. This role manages clinical study budgets, timelines, vendors, and mentors junior team members.

What you will do

• Manages operational aspects of clinical trials including CROs, central labs, and sites.
• Leads cross-functional internal study team meetings.
• Identifies, qualifies, and selects clinical trial sites and investigators.
• Supervises clinical trial execution including site start up, enrollment, and monitoring.
• Facilitates investigator meetings, kick-off meetings, and monitoring training.
• Develops and reviews study documents such as informed consent forms and study guidelines.
• Participates in the development of clinical trial protocols, amendments, and recruitment materials.
• Manages clinical study budgets and execution timelines.
• Attends and leads monitoring oversight visits.
• Maintains and oversees Trial Master File for assigned studies.

Required qualifications

• Bachelor's degree
• 8+ years of experience in clinical operations
• 4+ years in late stage trial operations with a sponsor company
• Experience in CRO, vendor and laboratory oversight
• Ability to travel for up to 30% of time, both domestic and international
• Detailed knowledge of GCP

Nice to have

• Advanced scientific degree
• Experience in Respiratory indications
• Knowledge of other relevant global regulatory requirements (ie FDA, EMA, and MHRA)

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

About the company

Generate Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. Founded in 2018, the company integrates machine learning with large-scale experimentation to design proteins with defined biological intent.