Clinical Trial Manager

Role overview

Generate Biomedicines is looking for a highly organized, proactive Clinical Trial Manager to help drive the operational delivery of late-stage studies within its Clinical Development organization. The position reports to the Director of Clinical Operations and acts as a central day-to-day coordinator for assigned trials.

The company runs clinical programs through contract research organizations and specialist vendors, so this role focuses on oversight, follow-through, issue escalation, and internal coordination rather than hands-on site execution. It is a strong fit for someone who is detail-oriented and wants to deepen their sponsor-side clinical operations experience.

What you will do

• Act as the main operational contact for assigned CROs and vendors, keeping an eye on study milestones, timelines, and any emerging risks or delays.
• Check study documents prepared by CROs for accuracy and completeness, including monitoring visit reports, site communications, protocol deviation records, and TMF content.
• Help coordinate startup tasks such as site activation tracking, collection of regulatory documents, and preparation for vendor kick-offs.
• Keep study trackers, schedules, and action logs current so cross-functional teams can easily see study progress and open actions.
• Join and support cross-functional study meetings, capture minutes, track follow-up items, and ensure outstanding actions are closed out.
• Monitor protocol deviations reported by CROs, work with internal teams and vendors on triage, and support documentation and resolution in a timely way.
• Assist with safety-reporting coordination by tracking SAE and SUSAR notifications and helping ensure timely distribution to sites and other stakeholders according to vendor responsibilities.
• Watch TMF completeness and inspection-readiness efforts, partnering with CROs to close filing gaps and maintain document-quality standards.
• Support IRB/IEC tracking across study sites, including follow-up on amendment approvals and annual renewals submitted by the CRO.
• Prepare and share enrollment, site performance, and operational metric summaries for clinical operations leadership on a recurring basis.
• Help with data review activities when needed and track CRO-led data cleaning progress.
• Review and track monitoring visits and monitoring visit reports to help ensure quality and alignment with the monitoring plan.
• Support invoice review and budget tracking by comparing CRO invoices with contracted activities and identifying mismatches.
• Coordinate data reconciliation at key study milestones with data management and the CRO.
• Assist with onboarding for CTAs joining the study team and serve as a day-to-day resource for study-related questions.

Candidate profile

This position is aimed at professionals with a bachelor’s degree, ideally in a scientific or health-related discipline, and at least 6 years of experience in clinical operations, clinical research, or a related area. Sponsor-side experience is considered an advantage.

Applicants should have a working knowledge of GCP, ICH guidance, and the clinical trial lifecycle. Experience coordinating with CROs or other clinical vendors is important, along with the ability to manage multiple trackers, deadlines, and action lists at once.

The role suits someone comfortable operating in an oversight-heavy, vendor-managed environment. Familiarity with clinical systems such as CTMS, EDC, and eTMF is expected. Strong communication skills, consistent follow-up, and timely escalation of issues are also important. Experience in oncology, immunology, or respiratory programs would be a plus. Travel may be required up to 20% domestically and/or internationally depending on study needs.

About Generate Biomedicines

Generate Biomedicines is a clinical-stage generative biology company focused on using AI to redesign how protein-based medicines are created. By combining machine learning with large-scale experimentation, the company aims to reduce the uncertainty, time, and cost involved in drug development.

Established in 2018, the organization is building a pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. Its integrated model brings together computational design and clinical development to move from traditional discovery toward systematic drug generation.

The company values cross-disciplinary collaboration, diverse perspectives, and a shared mission to deliver better medicines to patients faster.

Equal opportunity and agency notice

Generate Biomedicines provides equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status.

The company does not accept unsolicited resumes from recruitment or staffing agencies unless there has been direct contact from its internal Talent Acquisition team and a signed agreement is in place. Any unsolicited submission becomes the property of the company, and no referral or other fees will be owed.

Compensation and benefits

The base pay range for this role is estimated at $127,000 to $170,000 per year. Actual pay will depend on job-related skills, experience, internal equity, relevant education or training, and market conditions. The role is also eligible for an annual bonus, equity compensation, and a competitive benefits package.