Clinical Trial Manager

The Role: 

Generate Biomedicines is seeking an organized and proactive Clinical Trial Manager (CTM) to support the operational execution of late-stage clinical trials within our Clinical Development team. This role will report to the Director, Clinical Operations and will serve as a key day-to-day operational coordinator across assigned studies.

At Generate Biomedicines, clinical execution is carried out through a network of CROs and specialized vendors. The CTM plays a critical role in ensuring that these external partners stay on track monitoring deliverables, flagging issues, coordinating internally, and escalating to clinical operations leadership when needed. This is an excellent opportunity for a detail-driven professional looking to grow their clinical operations career on the sponsor side

Here's how you will contribute:

• Serve as a day-to-day operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership.
• Review CRO-generated study documents for completeness and quality, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries.
• Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor kick-off preparation.
• Maintain and update study trackers, timelines, and action logs; ensure cross-functional teams have visibility into study status and open items.
• Attend and support cross-functional study team meetings; document meeting minutes, track action items, and follow up on outstanding deliverables.
• Track and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure timely documentation and resolution.
• Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring timely distribution to sites and relevant stakeholders in line with vendor responsibilities.
• Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document quality standards.
• Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO.
• Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular basis.
• Contribute to data reviews as needed, and track data cleaning progress performed by CRO.
• Review and track monitoring visits and monitoring visit reports performed by CRO to ensure high quality and adherence to the monitoring plan.
• Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies.
• Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO.
• Support the onboarding of CTAs joining the study team and serve as a resource for day-to-day study questions.

The Ideal Candidate will have:

• Bachelor’s degree required; scientific or health-related field preferred. 
• 6+ years of experience in clinical operations, clinical research, or a related field; sponsor-side experience is a plus.
• Foundational understanding of GCP, ICH guidelines, and clinical trial processes.
• Experience working with or alongside CROs or clinical vendors in a coordination or support capacity.
• Strong attention to detail and ability to manage multiple trackers, timelines, and action items simultaneously.
• Comfortable working in a structured, vendor-managed model where the role is one of oversight and coordination rather than direct execution.
• Familiarity with clinical trial systems such as CTMS, EDC, and eTMF platforms.
• Clear communicator with the ability to follow up consistently and escalate issues in a timely manner.
• Familiarity with therapeutic areas such as oncology, immunology, and/or respiratory is a plus.
• Ability to travel up to 20% of the time, domestically and/or internationally, as study needs require.

About Generate Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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