Senior Manager, Clinical Data Management (Remote - US)

Senior Manager, Clinical Data Management

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, Clinical Data Management in the United States.

The Senior Manager, Clinical Data Management will lead and oversee all clinical data management activities for assigned studies, ensuring compliance, accuracy, and timely delivery of high-quality data across the drug development lifecycle. This role includes guiding internal teams and vendors, managing budgets, monitoring timelines, and implementing best practices to optimize clinical data operations. You will collaborate cross-functionally with project teams, provide expert guidance on regulatory and data standards, and contribute to continuous improvement initiatives. The ideal candidate is highly experienced in CDISC standards, SDTM requirements, and clinical trial data management, and thrives in a collaborative, fast-paced environment with a patient-centric focus.

Accountabilities

Lead assigned study / studies, ensuring timelines, deliverables, and data quality are met.

Provide expert guidance and decision-making for clinical data management processes from study start-up through database lock, reporting, and archiving.

Manage vendor / CRO oversight, including contract negotiations, invoice verification, and service quality monitoring.

Collaborate cross-functionally to resolve clinical data issues and maintain effective communication throughout the study lifecycle.

Develop, standardize, and implement data management SOPs, standards, and best practices.

Support regulatory audits, quality initiatives, and ensure compliance with GCP, ICH, CFR-Part 11, and other relevant regulations.

Mentor and guide internal study teams and contribute to team building and operational excellence.