Beam Therapeutics

Manager/Senior Manager, Clinical Data Management

Cambridge, MA · Senior · Full-time

Sponsorship not specified$130k-$190kDetected 9 days ago

GCPData VisualizationClinical TrialsFDA RegulatoryCRISPRCommunicationCollaborationProblem SolvingBiostatisticsRegulatory Affairs

About the role

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.
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.

Serve as the sponsor-side Clinical Data Management lead for assigned clinical studies.
Manage clinical data management activities from study start-up through database lock and archival.
Ensure clinical data are complete, accurate, and fit-for-purpose to support study objectives, interim analyses, clinical study reports, and regulatory submissions.
Drive issue resolution and proactively identify opportunities to improve data quality and operational efficiency.
Support oversight of external data sources including central laboratories and specialty vendors.
Lead cross-functional review activities for CRF design and database development and ensure adherence to Beam and/or CDASH/CDISC standards.
Support development and review of Data Management Plans and other study-level documentation.

5+ years of clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
Experience supporting Phase I-III clinical trials from study start-up through database lock.
Working knowledge of CDASH/CDISC standards, GCP/ICH requirements, and applicable regulatory expectations.
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform).
Experience managing CROs and external data vendors.
Familiarity with SDTM concepts and clinical data review processes.
Experience with data visualization or reporting tools such as J-Review or similar platforms.
BS or MS degree in a scientific, health-related, or technical discipline.
Strong analytical, organizational, and problem-solving skills.
Ability to manage multiple priorities and meet timelines in a fast-paced environment.
Excellent written and verbal communication skills.

Experience supporting late-stage or registrational clinical studies.
Experience in gene editing, cell therapy, rare disease, or other complex development programs.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.

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.

We are seeking a motivated and experienced Clinical Data Management professional to serve as the sponsor-side data management lead for assigned clinical studies within our growing development portfolio.

This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.