Lead, Clinical Data Management—Late-Stage Trials

Marea Therapeutics; South San Francisco (CA); On-site; USD 250,000 - 300,000; Full time

Job summary

Marea Therapeutics, a South San Francisco biotechnology company, seeks a Senior Director, Clinical Data Management to lead data management for late-stage programs. You will supervise CRO/vendor activities, ensure GCP-compliant data handling, and drive data quality across studies.

The role combines strategic oversight with hands-on leadership, including study lead responsibilities when needed, and requires collaboration with Biostatistics, Regulatory, and Clinical Operations.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 15+ years of progressive clinical data management experience in biotech/pharma/CRO.
• Experience leading data management for Phase 2/3 trials, sponsor environment preferred.
• Hands-on Data Management Lead from study start-up to database lock.
• Oversight of CROs and external vendors including quality, timelines, and deliverables.
• Strong experience with EDC systems (Medidata Rave) and data reconciliation.
• Knowledge of GCP and regulatory standards in data management.
• Familiarity with CDISC/SDTM and external data integration.
• Experience supporting regulatory submissions and audits.
• Ability to develop SOPs, governance, and data management standards.

Responsibilities

• Lead the Clinical Data Management function across programs.
• Provide hands-on study-level data management support when needed.
• Oversee data management lifecycle from startup to archival.
• Sponsor CRO/vendor oversight ensuring quality and timelines.
• Develop and maintain eCRFs, databases, edit checks, and reviews.
• Lead data cleaning, query management, and data reconciliation.
• Integrate external data (central lab, PK/PD, eCOA, imaging, safety).
• Establish data standards, templates, and governance across studies.
• Partner with operations, medical, statistics, and pharmacovigilance.
• Ensure CDISC standards support analyses and regulatory submissions.
• Support audits, inspections, and regulatory responses.
• Evaluate fit-for-purpose systems and automation to improve quality.
• Build and mentor the Clinical Data Management team.

Skills

Data management leadership

Vendor management

EDC systems

Regulatory compliance

Cross-functional collaboration

CDISC/SDTM knowledge

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Medidata Rave

eCRF design

Data management tools

CDISC/SDTM

Job description

Marea Therapeutics, a South San Francisco biotechnology company, seeks a Senior Director, Clinical Data Management to lead data management for late-stage programs. You will supervise CRO/vendor activities, ensure GCP-compliant data handling, and drive data quality across studies.

The role combines strategic oversight with hands-on leadership, including study lead responsibilities when needed, and requires collaboration with Biostatistics, Regulatory, and Clinical Operations.