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Beam Therapeutics · 2 weeks ago

Clinical Trial Manager

Cambridge, MA

Full-time

Hybrid

Senior Level, Lead/Staff

$125K/yr - $155K/yr

8+ years exp

Beam Therapeutics is a biotechnology company focused on precision genetic medicines. They are seeking an experienced Clinical Trial Manager to lead clinical trial operations, ensuring successful execution from start-up to close-out while adhering to industry standards.

BiotechnologyGeneticsMedicalTherapeutics

Comp. & Benefits

Hiring Manager

Sarah Oleson

Responsibilities

Have the skillset and experience to manage all project team activities related study start up, conduct and close out activities

Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget. Manage Change Orders with Sites (and Vendors when necessary), including checking for accuracy of invoices and cost of services versus accruals

Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF in collaboration with the CRO to manage the daily operational management activities of CROs and study vendors

Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities

Contribute to (or oversee the management of) the creation of the trial plans and site facing documents

Develop (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, Lab Manuals, Pharmacy Manuals, and any other trial-specific trainings for sites and internal team members

Support data management activities such as reviewing study-related support materials created by Data Management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan; participate in all the related activities and data cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries

Monitor (and escalate appropriately) vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc

Organize, oversee and/or participate in all study related meetings, including Investigator teleconferences, Clinical Study Team meetings, Vendor update calls, Safety Review Committee meetings, Data Safety Monitoring Board, etc. as appropriate

Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study

Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial

Qualification

Clinical trial managementGCP/ICH GuidelinesPhase I experienceBiotech/pharmaceutical experienceOrganizational skillsProblem solvingCollaborationCommunicationAttention to detail