The Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They will provide operational leadership and be accountable for of all Clinical Data Management activities throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR).

What you’ll do

• Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.
• Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
• Develops risk mitigation or action plans and oversees execution when appropriate.
• Reviews operational performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution.
• Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed.
• Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM Portfolio Lead, DM management. Develops appropriate risk mitigation, as needed.
• Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.

Who You Are

You are recognized as an operational specialist in clinical data flow and study execution by all cross-functional groups. You enjoy leading project teams , thrive on project deadlines, and are passionate about the clinical trial arena.  

• Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 7+ years relevant work experience with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as J-Review or Business Objects required
• Deep understanding of drug development and biopharmaceutical industry required
• Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience overseeing outsourced clinical trials work

Candidate must be located in the United States for this role.

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All your information will be kept confidential according to EEO guidelines.