Senior Clinical Trial Manager

Generate Biomedicines

Senior Clinical Trial Manager overseeing clinical trials for a COPD program. Collaborating with cross-functional teams and ensuring compliance across study timelines and budgets.

Posted 5/27/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $140,000 - $196,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Independently manages the operational aspects of Generate Biomedicines’ clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites, specifically late stage needs in Asthma/COPD.
Leads cross-functional internal study team meetings and meeting deliverables.
Identification, qualification, and selection of clinical trial sites and investigators alongside CRO including management of key relationships.
Leads day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs.
Facilitates investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
Management of clinical study budgets and execution timelines.
Ensures adherence to study timelines and project and program goals.
Attends and leads monitoring oversight visits and effective collaboration with CRO, Investigators, and site staff on any outcomes/findings.
Reviews study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
Collaboration on SOP development and promotion of standardized clinical business tools.
Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
Maintenance and oversight of Trial Master File for assigned studies.
Collaborate with QA and cross functional teams to ensure inspection readiness activities for assigned clinical trials, ensuring TMF completeness, audit preparedness, and compliance with GCP, SOPs, and applicable regulatory requirements.
Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).
Trains and mentors junior staff.

Requirements

What you’ll need

Bachelor’s degree required. Advanced scientific degree is preferred
8+ years of experiene in clinical operations, with at least 4+ years in late stage trial operations with a sponsor company
Experience in various therapeutic areas (Respiratory indications a strong plus)
Experience in CRO, vendor and laboratory oversight is required
Motivated self-starter who is capable of flourishing in a fast-paced environment
Creative problem solver with excellent communication and public speaking skills
Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Program/Portfolio Managers, Physicians, etc.)
Ability to travel for up to 30% of time, both domestic and international
Detailed knowledge of GCP. Knowledge of other relevant global regulatory requirements (ie FDA, EMA, and MHRA) is a plus.

Benefits

Comp & perks

Competitive benefits package
Annual bonus
Equity compensation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementvendor oversightpatient enrollmentdata flow metricsprotocol developmentbudget managementGCP complianceSOP developmentTrial Master File maintenanceclinical data review

Soft Skills

communication skillspublic speakinginterpersonal skillsorganizational skillsattention to detailproblem solvingleadershipmentoringcollaborationself-starter