Clinical Trial Manager

Generate Biomedicines•Somerville, MA

6d•$127,000 - $170,000

About The Position

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.

Requirements

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.

Nice To Haves

Sponsor-side experience is a plus.
Familiarity with therapeutic areas such as oncology, immunology, and/or respiratory is a plus.

Responsibilities

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.