Job details
Job description, work day and responsibilities
Manager/Senior Manager, Clinical Data Management
Position Overview: 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.
Reporting to the Senior Director of Data Management, this role is responsible for driving study-level data management activities from study start-up through database lock while ensuring high-quality, inspection-ready clinical data. The Manager/Senior Manager will work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Regulatory, and external partners to support the successful execution of clinical trials.
This role is ideal for an experienced clinical data manager who enjoys hands-on study ownership, cross-functional collaboration, and helping advance innovative therapies in a fast-paced biotechnology environment.
Primary Responsibilities: Lead Study-Level Data Management Activities
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.
Track and communicate study-level data management metrics, risks, and timelines.
Drive issue resolution and proactively identify opportunities to improve data quality and operational efficiency.
CRO and Vendor Oversight Serve as the primary data management contact for CROs and external vendors supporting assigned studies.
Oversee outsourced data management activities to ensure quality expectations and timelines are met.
Review deliverables and provide feedback on data management plans, CRF completion guidelines, edit checks, reconciliation plans, and data transfer specifications.
Support oversight of external data sources including central laboratories and specialty vendors.
Escalate risks, quality concerns, and timeline impacts with recommended mitigation strategies.
Database and Data Quality Management Lead cross-functional review activities for CRF design and database development and ensure adherence to Beam and/or CDASH/CDISC standards.
Review edit check specifications and coordinate user acceptance testing activities.
Support development and review of Data Management Plans and other study-level documentation.
Ensure appropriate reconciliation activities are conducted, including SAE and external vendor reconciliations.
Monitor data cleaning activities and partner with CROs to drive timely query resolution and database readiness.
Inspection Readiness and Cross-Functional Partnership
Beam Therapeutics is hiring for this role on CareerPlace.
Apply on the company website through Beam Therapeutics.
Imported from employer careers page. Source ref: 0f96a1a8360a.

