Senior Manager, Clinical Data Management

Generate Biomedicines

12h•$140,000 - $196,000

About The Position

The Senior Manager, Clinical Data Management will serve as the lead data manager for one or more clinical studies or programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock. This is a hands-on role for an experienced clinical data management professional who can independently drive execution, partner effectively with cross-functional teams and CROs, and maintain high data quality in a fast-paced environment. The successful candidate will be responsible for study execution, vendor oversight, database build testing activities, risk identification, data review, and data quality management. The role requires sound judgment, strong communication, accountability, and the ability to remain effective while managing competing priorities, changing requirements, and time-sensitive deliverables.

Requirements

Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred.
At least 7 + years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
Required hands-on experience with Medidata Rave EDC, eCOA and RTSM.
Demonstrated experience creating, running, reviewing, and interpreting Medidata Rave reports and listings.
Demonstrated experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting.
Solid understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes.
Strong knowledge of ICH-GCP and applicable regulatory requirements.
Experience reviewing CRO study finance reports, change notifications, and data management expenses.
Excellent written, verbal, and interpersonal communication skills, with the ability to communicate clearly with both technical and non-technical stakeholders.
Strong organizational and prioritization skills, with the ability to multitask, manage competing deadlines, and maintain attention to detail.

Nice To Haves

Experience with Spotfire or similar data visualization and analytics tools.
Experience working in a small to mid-sized biotechnology company environment.
Familiarity with CDISC standards, risk-based data review methodologies, and external vendor data integrations.

Responsibilities

Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables.
Review and approve key data management documents, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation.
Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and related configuration; create, run, review, and interpret Rave reports and listings to support data review, cleaning, reconciliation, and oversight.
Plan, perform, and document testing of database builds, edit checks, eCRFs, derivations, and system functionality; identify defects, assess impact, track resolution, and verify fixes through UAT.
Lead data review, query management, external data reconciliation, and database lock activities, including oversight of CRO and vendor deliverables.
Monitor data quality, review metrics and study timelines to identify risks early, and support external data integrations, transfer specifications, reconciliation activities, and inspection readiness.
Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct; provide clear, timely updates on data management activities, risks, decisions, and timelines, and escalate issues as appropriate.
Review CRO financial reports, change notifications, and associated data management expenses to support appropriate scope, budget, and timeline oversight.
Build constructive working relationships and navigate challenging situations with professionalism, respect, and a solutions-oriented approach.
Contribute to the continuous improvement of data management processes, standards, tools, and templates; share best practices and align day-to-day decisions with company goals, study priorities, patient safety, and program success.