Clinical Trial Manager

Role overview

Generate Biomedicines is looking for a highly organized Clinical Trial Manager to help drive the operational delivery of late-stage clinical studies. Reporting to the Director of Clinical Operations, this person will act as the primary day-to-day coordinator across assigned trials and ensure studies stay on schedule and aligned with expectations.

The company runs its clinical execution through CROs and specialist vendors, so this role is centered on oversight, issue management, and internal coordination. It is well suited to someone who enjoys keeping multiple moving parts aligned and wants to build a sponsor-side career in clinical operations.

What you will do

• Act as the main operational contact for assigned CROs and vendors, monitoring timelines and deliverables while escalating delays or risks to clinical operations leadership.
• Assess study documents prepared by CROs for quality and completeness, including monitoring visit reports, site communications, protocol deviation records, and TMF entries.
• Help coordinate study start-up work such as site activation tracking, collection of regulatory documents, and preparation for vendor kick-off activities.
• Keep study trackers, timelines, and action logs current so internal teams can clearly see study progress and open items.
• Join cross-functional study meetings, capture minutes, follow up on action items, and keep deliverables moving.
• Monitor protocol deviations reported by CROs, work with vendors and internal stakeholders to resolve them, and ensure documentation is completed on time.
• Support safety-reporting coordination by tracking SAE/SUSAR notifications and making sure they are shared with sites and other stakeholders according to vendor responsibilities.
• Oversee TMF completeness and help with inspection-readiness activities by closing filing gaps and maintaining document quality.
• Track IRB/IEC status across sites, including amendments and annual renewals submitted by the CRO.
• Prepare and share enrollment, site performance, and operational metrics with clinical operations leadership on a recurring basis.
• Assist with data review activities as needed and monitor progress on data cleaning completed by the CRO.
• Review monitoring visits and related reports to confirm they meet the monitoring plan and quality expectations.
• Support invoice review and budget tracking by matching CRO invoices to contracted activities and highlighting discrepancies.
• Coordinate data reconciliation at key study milestones with data management and the CRO.
• Help onboard CTAs joining the study team and serve as a resource for everyday study-related questions.

Candidate profile

The ideal candidate will bring strong attention to detail, the ability to manage several trackers and timelines at once, and comfort working in a vendor-led oversight model. Experience in clinical operations, clinical research, or a related environment is required, and sponsor-side experience is considered an advantage.

A solid working knowledge of GCP, ICH guidelines, and the clinical trial process is expected, along with experience collaborating with CROs or clinical vendors. Familiarity with CTMS, EDC, and eTMF systems is also important. Clear communication skills, steady follow-through, and the ability to escalate issues promptly are essential.

Exposure to oncology, immunology, or respiratory programs is beneficial. This position may require travel of up to 20% domestically and/or internationally, depending on study needs.

Education and experience

A bachelor’s degree is required, preferably in a scientific or health-related discipline. The role also calls for at least 6 years of experience in clinical operations, clinical research, or a similar field.

About Generate Biomedicines

Generate Biomedicines is a clinical-stage generative biology company focused on designing proteins with specific biological intent. By combining machine learning with large-scale experimentation, the company aims to reduce uncertainty, time, and cost in the development of protein-based medicines.

Founded in 2018, the organization is advancing both clinical and preclinical programs across several disease areas and protein modalities. Its model brings computational design and clinical development together to support a systematic approach to drug generation.

Equal opportunity and agency notice

Generate Biomedicines is an equal opportunity employer and considers applicants without regard to 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 the candidate has been directly contacted by its internal Talent Acquisition team. Any resume submitted without a signed agreement will become the property of the company, and no referral or other fees will be owed.

Compensation and benefits

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