Clinical Trial Manager

Beam Therapeutics•Cambridge, MA

11d

About The Position

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to join our growing Clinical Operations team. In this role, you will serve as the operational lead - driving timelines, fostering collaboration, and ensuring the successful execution of clinical trials. The CTM will oversee day-to-day activities throughout the clinical trial lifecycle. Key responsibilities include managing start-up, conduct, and close-out activities in alignment with industry and corporate standards within ICH/GCP Guidelines.

Requirements

Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials.
Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes.
Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
Ability and willingness to travel up to 20% (domestic and international).

Nice To Haves

Phase I experience is strongly preferred; a background in rare disease and/or metabolic disorders is highly desirable, and experience with cell & gene therapy is a plus.

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.