
Senior Data Operations Manager
13 hours ago
Job Title: Senior Data Operations Manager
">About the Role:
">The ideal candidate will have extensive experience in clinical trial/data management and data operations, with a strong background in electronic data capture (EDC) systems management and clinical data operations.
">Key Responsibilities:
">- Lead and manage a team of data managers to ensure timely delivery of high-quality data for clinical trials.">
- Design and implement efficient data management strategies to meet project requirements.">
- Maintain and improve existing clinical trial management system (CTMS) platforms and EDC systems to ensure compliance with regulatory requirements.">
- Collaborate with cross-functional teams to resolve data-related issues and improve overall data quality.">
Requirements:
">- 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 and EDC systems.">
- Strong background in EDC systems management and clinical data operations.">
- Experience in pharmaceutical, biotechnology, or contract research organization (CRO) environment across multiple therapeutic areas.">
Technical Expertise:
">- CTMS configuration and administration skills.">
- Deep knowledge of EDC platforms and system integrations.">
- Strong understanding of regulatory requirements, including HIPAA, FDA, EMA, and ICH-GCP.">
- Experience with electronic systems validation and 21 CFR Part 11 compliance.">
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