Senior Manager, Clinical Data Management – External Data Management

This is a fully remote position, open to applicants in California.

📋 Description

• Lead and oversee external data management tasks for designated clinical studies.

• Create and uphold Data Transfer Agreements (DTAs) and specifications for external data.

• Organize and execute test data transfers, ensuring quality control through hands-on involvement.

• Import, verify, and reconcile datasets from external sources.

• Work collaboratively with Clinical Operations, Biostatistics, and Regulatory teams.

• Act as the subject matter expert in external data management during regulatory inspections.

⛳️ Requirements

• MS/BS degree in life sciences, health informatics, computer science, or a related discipline.

• Over 8 years of advancing clinical data management experience (or 12 years with a Bachelor's degree).

• Demonstrated proficiency in handling intricate external data.

• Strong familiarity with EDC systems and clinical data regulations.

• Expertise in SAS (or similar tools) for data validation and reconciliation.

• Comprehensive knowledge of ICH-GCP and 21 CFR Part 11.

• Capability to work autonomously with minimal supervision while juggling multiple priorities.

🏝️ Benefits

• Health insurance options including medical, dental, vision, and basic life insurance.

• 401k matching program.

• Annual discretionary target bonus.

• Stock options available.

• 20 days of paid time off (PTO).

• 10 paid holidays throughout the year.

• Company-wide winter shutdown.