Senior Manager, Clinical Data Management, Study Lead

What you'll do

• Serve as the primary data management study lead for study teams, CROs, and external vendors.
• Oversee data management activities from study start-up through database lock and archiving.
• Provide sponsor oversight of CRO data management work to identify and resolve gaps.
• Review and approve key study documentation including data management plans and CRF designs.
• Maintain inspection readiness and eTMF documentation for quarterly compliance reviews.
• Monitor data quality, deliverable timelines, and proactively identify project risks.
• Manage, coach, and develop data management staff through recruitment and performance management.
• Recommend process improvements and lead cross-functional initiatives as a subject matter expert.

What we're looking for

• Bachelor’s degree in mathematics, Science, or a related field.
• 8+ years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry.
• Proven record of leading studies and study teams in a data processing environment.
• Sophisticated knowledge of 21 CFR Part 11, ICH-GCP, and CDISC regulations and standards.
• Strong problem-solving, project management, and communication skills to motivate virtual teams.
• 3+ years of people management experience (preferred).
• Certified Clinical Data Manager (CCDM) certification (preferred).