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Contact: Lauren Scutero - lscutero@penfieldsearch.com
No 3rd party candidates

On-Site - Candidates must be local to Palo Alto

Description
We are seeking a dedicated and detail-oriented Manager, Data Management to support data management activities for clinical trials. This role will contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready data. The ideal candidate will bring strong hands-on experience and a collaborative mindset, working closely with cross-functional teams to drive successful trial execution and regulatory submissions.

Responsibilities

• Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
• Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
• Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
• Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
• Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
• Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting.
• Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).

Education / Qualifications

• Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
• Experience managing study-level data management activities and working with external vendors.
• Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
• Demonstrated experience supporting regulatory submissions is a plus.
• Strong problem-solving, organizational, and communication skills.