Clinical Trial Manager

Summary

Join Generate:Biomedicines, a pioneering therapeutics company using machine learning and biological engineering to create breakthrough medicines. Support operational planning and execution of clinical trials, from study start-up to close-out. Manage CROs, central labs, and other clinical vendors. Contribute to protocol development and review study-related documents. Oversee site selection and initiation activities, maintaining strong communication with investigators and site staff. Maintain the Trial Master File (TMF) and ensure inspection readiness. This role offers a chance to contribute to cutting-edge clinical programs and gain hands-on experience in a collaborative team.

Requirements

• Bachelor’s degree in life sciences or related field; advanced degree a plus
• 3-5 years of experience in clinical trial operations, with at least 1 year independently managing aspects of a trial
• Working knowledge of GCP, ICH guidelines, and global regulatory requirements
• Demonstrated ability to manage vendors and collaborate across functions
• Strong written and verbal communication skills
• Proficiency in Microsoft Office and relevant clinical systems (e.g., EDC, eTMF)
• Organized, proactive, and detail-oriented, with a problem-solving mindset
• Bachelor’s degree required; life sciences focus preferred

Responsibilities

• Support operational planning and execution of clinical trials from study start-up through close-out
• Manage CROs, central labs, and other clinical vendors to ensure delivery of key milestones
• Contribute to protocol development and review study-related documents including CRFs, ICFs, and study manuals
• Oversee site selection and initiation activities; maintain strong communication with investigators and site staff
• Participate in clinical study team meetings, support cross-functional coordination, and track study timelines
• Maintain Trial Master File (TMF) and ensure inspection readiness
• Track study metrics and assist in data cleaning and reconciliation activities
• Assist in review of monitoring reports and ensure follow-up on key findings
• Support budgeting, invoice reconciliation, and vendor contract management
• Coordinate investigator meetings and other study-related events

Preferred Qualifications

• Experience in respiratory, immunology, or oncology trials
• Prior exposure to IND-enabling studies or global trial execution
• Familiarity with AI-driven platforms or digital tools in clinical research

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package