What You'll Do The Senior Manager, Clinical Data Management (CDM), reporting to Director, Clinical Data Strategy and Management, will play a pivotal role in a dynamic, cross-functional clinical development team focused on advancing treatments for endocrine and metabolic disorders. This role will provide hands-on leadership on day-to-day data management activities across MBX portfolio to ensure high quality and inspection ready clinical databases and data from all sources, while serving as a key data management partner to Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Safety, Quality, Medical Writing, and external data vendors.
- Lead day-to-day clinical data management operations across MBX programs.
- Provide oversight of EDC and eDiary/eCOA design, development, and ongoing database modifications, including review and approval of specifications. Ensure core team's input is incorporated for robust design.
- Oversee and perform User Acceptance Testing (UAT), validation activities, and documentation to ensure compliant, high-quality databases.
- Develop, maintain, and update Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), and related DM documentation.
- Lead data review meetings, including delivery of data listings to clinical and medical teams.
- Lead proactive data surveillance and critical data reviews/reconciliations to ensure data completeness, quality, and timely availability of primary and key secondary endpoint data.
- Oversee CRO data management teams and all external data vendors, including execution of Data Transfer Agreements and oversight of timely data transfers (and quality).
- Oversee integration and reconciliation of external data sources, including IRT, eCOA/eDiary, central laboratory, specialty laboratory, imaging, and safety data.
- Lead database interim and final lock planning and execution, including timeline development, risk tracking, and on-time data delivery to Biostatistics.
- Oversee final subject data profile generation format review and deliveries to the sites.
- Ensure TMF data management documentation quality and QC, including timely filing, completeness, and inspection readiness.
- Ensure all data management activities and documents are in inspection ready state.
What You'll Bring - Master's degree in Life Sciences, Health Sciences, Data Management, Computer Science, or a related field; advanced degree is a plus.
- Experience with Medidata Rave or equivalent EDC systems. Demonstrated hands-on experience with EDC design, database development, specifications review, UAT oversight, ongoing database modifications, and lock.
- Experience with eCOA/eDiary systems, including design review, specifications review, UAT oversight, ongoing database modifications and vendor management.
- Experience with data from multiple sources including, but not limited to central laboratory, IRT, specialty labs, etc.
- Ability to lead proactive data surveillance and critical data review to ensure completeness and integrity of primary and key secondary endpoint data and support timely study decision-making.
- 9+ years of experience in Clinical Data Management within biotech, pharmaceutical, and/or CRO environments. Demonstrate experience serving as Lead Data Manager on global Phase 2 and Phase 3 clinical studies.
- Strong experience authoring and maintaining Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), Data Transfer Agreement (DTA), Data Oversight Plan (DOP), and other DM documentation.
- Proven ability to oversee CRO data management teams and external data vendor partners.
- Experience supporting database lock planning and execution, including delivery to Biostatistics.
- Solid knowledge of ICH-GCP, regulatory requirements, and inspection readiness, including TMF documentation expectations related to Data Management.
- Experience contributing to cross-functional clinical teams. Strong organizational, communication, and problem-solving skills, with the ability to operate effectively in a fast-paced development environment.
- Experience managing data management deliverables across multiple studies and vendors.
