Clinical Data Operations Leader
13 hours ago
We are seeking a seasoned professional to fill a critical role in our organization.
Key Responsibilities:- Lead a team of clinical data managers and ensure timely delivery of projects.
- Develop and implement strategies for efficient clinical trial data management.
- Collaborate with cross-functional teams to identify and address data quality issues.
- Provide training and mentorship to junior staff members.
- 10-15 years of experience in clinical trial/data management and data operations.
- Minimum 4-5 years of people management experience with proven supervisory skills.
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
- Strong background in EDC systems management and clinical data operations.
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
- CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
- Deep knowledge of EDC platforms and system integrations.
- Strong understanding of regulatory requirements (HIPAA, FDA, EMA, ICH-GCP).
- Experience with electronic systems validation and 21 CFR Part 11 compliance.
This role offers a unique opportunity for a seasoned professional to provide strategic leadership and technical expertise. If you have a passion for clinical data management and want to take your career to the next level, this may be the ideal position for you.
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