Clinical Data Management Manager – Trials

Penfield Search Partners Ltd.; Palo Alto (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Penfield Search Partners Ltd. in Palo Alto, CA is seeking a Manager, Data Management to lead clinical data management activities within trials and ensure data integrity and readiness for submissions.

The role requires hands-on oversight of databases, eCRFs, and vendor performance, with collaboration across Clinical Operations, Biostatistics, Regulatory Affairs, and IT. The ideal candidate will bring 7+ years in clinical data management in biotech/pharma, familiarity with CDISC/SDTM, and

Qualifications

• 7+ years of clinical data management in biopharma/CRO.
• Experience overseeing study-level data management activities.
• Experience managing external data management vendors.
• Familiarity with Medidata RAVE, Oracle Clinical, or Veeva.
• Knowledge of CDISC/SDTM standards.
• Experience supporting regulatory submissions.
• Strong problem-solving and analytical skills with attention to detail.
• Excellent organizational and communication skills.

Responsibilities

• Design, develop, and validate study-level databases and eCRFs.
• Oversee data cleaning, query resolution, and high-quality datasets.
• Oversee external data management vendors and timelines.
• Prepare submission-ready datasets for regulatory filings (NDA, BLA, MAA).
• Ensure data management compliance with GCP, FDA, EMA.
• Support audit and inspection readiness.
• Collaborate with cross-functional teams for data integration and reporting.
• Identify opportunities to improve data systems and processes.

Skills

Data management

Vendor management

CDISC/SDTM

Medidata RAVE

Veeva

eCRF design

Regulatory submissions

GCP/FDA/EMA knowledge

Project management

Communication

Education

Bachelor's degree in Life Sciences

Tools

Medidata RAVE

Oracle Clinical

Veeva

Job description

Penfield Search Partners Ltd. in Palo Alto, CA is seeking a Manager, Data Management to lead clinical data management activities within trials and ensure data integrity and readiness for submissions.

The role requires hands-on oversight of databases, eCRFs, and vendor performance, with collaboration across Clinical Operations, Biostatistics, Regulatory Affairs, and IT. The ideal candidate will bring 7+ years in clinical data management in biotech/pharma, familiarity with CDISC/SDTM, and