
Clinical Trials Management Professional
6 hours ago
We are seeking a highly experienced Clinical Trial/Data Management Specialist to oversee the management of clinical trial data, ensuring compliance with regulatory requirements and industry standards.
- This role involves overseeing the management of clinical trial data, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Manage and maintain CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar) to ensure seamless data operations.
- Oversee EDC system management and clinical data operations, including electronic systems validation and 21 CFR Part 11 compliance.
- Lead and manage a team of data managers, providing guidance on best practices and industry trends.
Requirements:
- Minimum 10-15 years of experience in clinical trial/data management and data operations.
- 4-5 years of people management experience with proven supervisory skills.
- Extensive experience with CTMS platforms, EDC systems management, and clinical data operations.
Technical Expertise:
- 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).
Preferred Qualifications:
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
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