Senior Manager, Clinical Data Management, Study Lead
New
J
JobgetherClinical research
US; based in the United StatesFull-TimeManager
SalaryAnnual salary range: $134,400–$219,200
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Job Details
- Experience
- At least eight years of clinical data management experience; at least three years of people management experience is preferred.
- Required Skills
- Project Management
Requirements
- Bachelor’s degree in Mathematics, Science, or a related field.
- At least eight years of clinical data management experience within biotechnology, pharmaceutical, healthcare, or related industries.
- Demonstrated experience leading clinical studies and study teams in a data processing or clinical data management environment.
- Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
- Experience overseeing CROs and external data vendors, reviewing study documentation, monitoring deliverables, and resolving data quality or compliance issues.
- Understanding of clinical data management processes across study start-up, data collection, quality oversight, database lock, and archiving.
- Problem-solving, project management, organizational, and analytical skills.
- Written and verbal communication skills and ability to influence stakeholders and coordinate virtual teams in a matrixed environment.
- Ability to manage competing priorities, identify risks, and drive issues to resolution while maintaining study quality and timelines.
- Ability to work across cross-functional teams and support continuous improvement in a regulated clinical research environment.
- At least three years of people management experience preferred.
- Certified Clinical Data Manager (CCDM) certification preferred.
Responsibilities
- Serve as the clinical data management study lead and primary point of contact for study teams, CROs, and external data vendors across multiple trials.
- Oversee clinical data management activities from study start-up and planning through database lock and final data archiving.
- Provide sponsor oversight of CRO data management activities, evaluate deliverables, identify gaps, and ensure issues are addressed.
- Review and approve data management plans, CRF designs, and data transfer specifications.
- Maintain inspection-ready study documentation and ensure eTMF records meet documentation standards and quarterly compliance review requirements.
- Monitor data quality, timelines, deliverables, and operational risks; escalate concerns and drive resolution.
- Lead, coach, and develop clinical data management team members, including supporting recruitment and performance management.
- Coordinate study deliverables and resolve data management challenges with cross-functional stakeholders.
- Identify opportunities to improve data management processes, operational efficiency, and consistency across studies.
- Lead cross-functional initiatives and provide subject matter guidance, knowledge sharing, and training on clinical data management practices.
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