Senior Clinical Data Management Lead

Penfield-Search-Partners-2; Palo Alto (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Penfield-Search-Partners-2 is assisting a biopharmaceutical client in Palo Alto seeking a Manager, Data Management to lead clinical data management activities and ensure data integrity across trials in Ophthalmology.

You will oversee database development, data cleaning, vendor oversight, and the preparation of submission-ready datasets for regulatory filings, while collaborating with Clinical Operations, Biostatistics, Regulatory Affairs, IT, and other teams.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 7+ years of clinical data management experience.
• Hands-on experience managing study-level data management activities.
• Experience overseeing external data management vendors.
• Familiarity with CDISC and SDTM.

Responsibilities

• Support design, development, and validation of clinical trial databases and eCRFs at the study level.
• Oversee data cleaning, query management and resolution, and delivery of high-quality datasets.
• Partner with external data management vendors to ensure timely, high-quality deliverables.
• Prepare, review, and validate submission-ready datasets for regulatory filings (NDA, BLA, MAA).
• Ensure data management activities comply with GCP, FDA, and EMA requirements.
• Support audit and inspection readiness activities.
• Collaborate across Clinical Operations, Biostatistics, Regulatory Affairs, IT, and other teams.
• Contribute to implementation and optimization of clinical data systems (EDC, data review platforms).
• Identify opportunities to improve data management processes and study execution.

Skills

Clinical data management

Vendor management

Data quality oversight

eCRF design

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences

Tools

Medidata RAVE

Oracle Clinial

Veeva

Job description

Penfield-Search-Partners-2 is assisting a biopharmaceutical client in Palo Alto seeking a Manager, Data Management to lead clinical data management activities and ensure data integrity across trials in Ophthalmology.

You will oversee database development, data cleaning, vendor oversight, and the preparation of submission-ready datasets for regulatory filings, while collaborating with Clinical Operations, Biostatistics, Regulatory Affairs, IT, and other teams.