
Clinical Data Lead
10 hours ago
We are seeking an experienced Senior Clinical Data Manager to fill a key role in our organization.
- The ideal candidate will have 10-15 years of experience in clinical trial/data management and data operations, with a strong background in EDC systems management and clinical data operations.
- They will also have experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
Key Responsibilities:
- Lead a team of data managers in the planning, execution, and delivery of clinical trials.
- Develop and maintain CTMS platforms, ensuring seamless integration with EDC systems.
- Ensure compliance with regulatory requirements, including HIPAA, FDA, EMA, and ICH-GCP.
- Collaborate with cross-functional teams to drive business objectives and improve processes.
Required Skills and Qualifications:
- 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.
Benefits:
- Opportunity to work on complex clinical trials and develop expertise in data management.
- Chance to collaborate with experienced professionals and contribute to business growth.
- Professional development opportunities to enhance skills and knowledge.
Others:
- Familiarity with electronic systems validation and 21 CFR Part 11 compliance.
- Understanding of regulatory requirements and industry standards.
- Able to work effectively in a team environment and communicate clearly.
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