Lead Clinical Data Manager

Meet Life Sciences; Redwood City (CA); Hybrid; USD 130,000 - 190,000; Full time

Job summary

Meet Life Sciences in California is seeking an experienced Lead Clinical Data Manager to drive data management across oncology trials, from start-up to database lock.

You will partner with Clinical Operations, Biostatistics, Medical, and CROs, provide hands-on Medidata Rave EDC leadership, and help shape data standards in a hybrid Redwood City setting.

Qualifications

• 5+ years of clinical data management experience.
• Direct experience leading Phase 3 oncology clinical trials is required.
• Experience managing CROs and external data management vendors.
• Strong understanding of CDM processes from study start-up through database lock.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead clinical data management activities from study start-up through database lock.
• Provide data management oversight for Phase 3 oncology studies.
• Develop and review data management plans, CRFs, edit checks, and data review specs.
• Manage database development, validation, cleaning, reconciliation, and lock activities.
• Provide hands-on expertise with Medidata Rave EDC (build, testing, data review, issue resolution).
• Partner with CROs and external vendors to meet timelines and deliverables.
• Collaborate with Clinical Ops, Biostatistics, Medical, Safety, and Programming teams.
• Identify and resolve data-related issues and provide status updates to study teams.
• Support development and implementation of data management processes and standards.

Skills

Clinical data management

Phase 3 Oncology

Vendor management

Cross-functional collaboration

Data review & QC

Education

Bachelor's degree in Life Sciences

Tools

Medidata Rave EDC

Job description

A growing biotech company is seeking an experienced Lead Clinical Data Manager to support clinical development programs, with a focus on oncology studies. This individual will provide clinical data management leadership across clinical trials and work closely with Clinical Operations, Biostatistics, Medical, and external CRO partners.

Responsibilities

• Lead clinical data management activities for assigned clinical trials from study start-up through database lock.
• Provide data management oversight for Phase 3 oncology studies.
• Develop and review data management plans, CRFs, edit checks, data review specifications, and other study documentation.
• Manage and oversee clinical database development, validation, data cleaning, reconciliation, and database lock activities.
• Provide hands‑on expertise with Medidata Rave EDC, including database build, testing, data review, and issue resolution.
• Partner with CROs and external vendors to ensure study timelines, data quality, and deliverables are met.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical, and Safety teams.
• Identify and resolve data-related issues and provide ongoing status updates to study teams.
• Support the development and implementation of data management processes and standards.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, or a related field.
• 5+ years of clinical data management experience, preferably within biotech or pharmaceutical environments.
• Direct experience leading Phase 3 oncology clinical trials is required.
• Strong hands‑on experience with Medidata Rave EDC is required.
• Experience managing CROs and external data management vendors.
• Strong understanding of clinical data management processes from study start-up through database lock.
• Excellent communication, organizational, and cross-functional collaboration skills.
• Ability to work effectively in a hybrid environment in Redwood City, CA.

Preferred

• Experience supporting multiple clinical programs or studies simultaneously.
• Experience with other clinical data systems and technologies.
• Experience working in a small or mid‑sized biotech environment.
• Experience with oncology indications and complex Phase 3 trial designs.