Full Job Description
When & where:
• Location: US
• Work model: Remote
Discover your role:
• Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials
• Oversee data management activities from study start-up through database lock and archiving
• Provide sponsor oversight of CRO data management work, identifying gaps and driving them to resolution
• Review and approve key study documentation, including data management plans, CRF design, and data transfer specifications
• Maintain inspection readiness and eTMF documentation to meet quarterly compliance reviews
• Monitor data quality, deliverable timelines, and risks, calling out issues proactively
• Manage, coach, and develop data management staff, including recruitment and performance management
• Recommend process improvements, lead cross-functional initiatives, and act as a subject matter expert delivering training
This role requires:
• 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 applicable regulations and standards, including 21 CFR Part 11, ICH-GCP, and CDISC
• Strong problem-solving, project management, and communication skills, with the ability to motivate virtual teams in a matrix environment.
• 3+ years of people management experience preferred.
• Certified Clinical Data Manager (CCDM) certification preferred.
Salary Range (annually)
$134,400.00 - $219,200.00
