Clinical Data Management Lead for Phase 2/3 Trials

Regulatory Jobs; Burlington (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

MBX Biosciences, a clinical-stage biopharmaceutical company, seeks a Senior Manager, Clinical Data Management to lead day-to-day data management across MBX programs, ensuring high-quality, inspection-ready databases from diverse data sources. You will guide EDC/eCOA design, UAT oversight, and data transfers with cross-functional teams.

Ideal candidate has 9+ years in CDM in biotech/pharma/CROs, and hands-on experience with Medidata Rave, ICH-GCP regulations, and TMF documentation.

Qualifications

• Master’s degree in Life Sciences, Health Sciences, Data Management, Computer Science, or a related field.
• Hands-on experience with Medidata Rave or equivalent EDC systems; EDC design, database development, specifications review, UAT oversight, and lock.
• Experience with eCOA/eDiary systems and vendor management.
• Experience with data from multiple sources (central labs, IRT, specialty labs).
• Ability to lead proactive data surveillance and data reviews for endpoint data.
• 9+ years in Clinical Data Management in biotech/pharma/CRO; lead data manager on global Phase 2/3 studies.
• Experience authoring Data Management Plans, CRF guidelines, DTAs, DOPs, and DM documentation.
• Proven ability to oversee CRO teams and data vendors.
• Knowledge of ICH-GCP, regulatory requirements, TMF expectations.

Responsibilities

• Lead day-to-day clinical data management operations across MBX programs.
• Oversee EDC and eDiary/eCOA design, development, and database modifications with robust specifications.
• Perform UAT oversight, validation activities, and documentation for compliant databases.
• Develop and maintain Data Management Plans, CRF Completion Guidelines, DTAs, and related DM docs.
• Lead data review meetings and deliver data listings to clinical and medical teams.
• Oversee data surveillance and reconciliations for data completeness and quality.
• Manage CRO data management teams and external data vendors, including data transfers.
• Coordinate integration of external data sources (IRT, eCOA/eDiary, labs, imaging, safety).
• Lead database lock planning and data delivery to Biostatistics.
• Ensure TMF data management documentation quality and inspection readiness.

Skills

Medidata Rave

EDC design

UAT oversight

Data management

Cross-functional

Lead data mgmt

Regulatory compliance

TMF documentation

Education

Master’s degree in Life Sciences

Tools

Regulatory databases

Job description

MBX Biosciences, a clinical-stage biopharmaceutical company, seeks a Senior Manager, Clinical Data Management to lead day-to-day data management across MBX programs, ensuring high-quality, inspection-ready databases from diverse data sources. You will guide EDC/eCOA design, UAT oversight, and data transfers with cross-functional teams.

Ideal candidate has 9+ years in CDM in biotech/pharma/CROs, and hands-on experience with Medidata Rave, ICH-GCP regulations, and TMF documentation.