Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager providing oversight for clinical trial data within pharma and biotech settings. Ensuring compliance and excellence in data integrity and management throughout studies.
Responsibilities:
- Provide data management expertise and oversight for assigned studies
- Review and approve study documents; deliver training as needed
- Allocate studies and handle escalations in consultation with CDM Manager
- Create and update study data management documentation, including specifications and validation plans
- Collaborate with project teams to ensure accurate data collection, cleaning, and transfers
- Participate in Kick-Off Meetings, sponsor meetings, and study team discussions
- Perform study setup, including database structure and edit check criteria
- Validate data capture configurations and ensure compliance with regulatory guidelines
- Mentor team members and delegate assignments to encourage growth
- Support hiring and training of new team members
Requirements:
- Bachelor’s degree in Computer Science, Life Sciences, or equivalent experience
- 4+ years of experience in clinical data management within pharma, biotech, or CRO
- Proven expertise in data management systems and tools; familiarity with SQL and SAS desirable
- Strong attention to detail and ability to resolve escalations
- Knowledge of clinical research, GCP, GCDMP, and regulatory requirements
- Understanding of software development cycle and 21 CFR Part 11 compliance
- Excellent communication, documentation, and organizational skills
- Ability to work independently and adapt to changing priorities
Benefits:
- Competitive compensation
- Medical, dental, and vision coverage
- Flexible and paid time off
- Remote and hybrid work options
- Tuition reimbursement
- Employee assistance and wellness programs
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