Clinical Data Management Manager – Trials & Submissions

Penfield Search Partners Ltd.; Palo Alto (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Penfield Search Partners Ltd. is partnering with a biopharmaceutical company in Palo Alto to recruit a Manager, Data Management.

The role supports clinical trial data management activities and ensures data integrity from study design through submission-ready datasets. You will lead database development, data cleaning, vendor oversight, and regulatory submissions (NDA/BLA/MAA) while ensuring GCP, FDA and EMA compliance.

Qualifications

• Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of clinical data management experience in biotech/pharma/CRO.
• Hands-on experience managing study-level data management activities.
• Experience overseeing external data management vendors.
• Familiarity with Medidata RAVE, Oracle Clinical, and/or Veeva.
• Knowledge of CDISC and SDTM.
• Regulatory submissions experience preferred.
• Strong problem solving, analytical, and detail orientation.
• Excellent organizational and PM skills.

Responsibilities

• Design, develop and validate study-level databases and eCRFs.
• Oversee data cleaning, queries, and delivery of high-quality datasets.
• Manage external data management vendors and monitor timelines.
• Prepare submission-ready datasets for regulatory filings (NDA/BLA/MAA).
• Ensure compliance with GCP, FDA, and EMA requirements.
• Support audit and inspection readiness.
• Collaborate with Clinical Ops, Biostatistics, Regulatory Affairs, IT.
• Support data systems optimization, including EDC platforms.
• Identify opportunities to improve data management processes.

Skills

Clinical data management

Vendor management

Regulatory submissions

Data standards (CDISC/SDTM)

Communication skills

Education

Bachelor's degree in Life Sciences/Data Science/Computer Science

Tools

Medidata RAVE

Oracle Clinical

Veeva

Job description

Penfield Search Partners Ltd. is partnering with a biopharmaceutical company in Palo Alto to recruit a Manager, Data Management.

The role supports clinical trial data management activities and ensures data integrity from study design through submission-ready datasets. You will lead database development, data cleaning, vendor oversight, and regulatory submissions (NDA/BLA/MAA) while ensuring GCP, FDA and EMA compliance.