
Senior Clinical Data Management Leader
2 days ago
We are seeking a highly experienced Senior Clinical Data Manager to lead our clinical data management team. As a Senior Clinical Data Manager, you will be responsible for overseeing the management of clinical data across various phases of a clinical trial.
About the RoleThis is an exciting opportunity for a seasoned professional to take on a leadership role in our clinical data management department. The successful candidate will have extensive experience in managing clinical trials and leading teams.
Key Responsibilities:- Manage and oversee the day-to-day activities of a team of data managers to ensure smooth execution of clinical trials.
- Collaborate with cross-functional teams, including clinical operations, statistics, and regulatory affairs, to ensure compliance with regulatory requirements and optimal study design.
- Develop and implement data management strategies to ensure high-quality data and efficient use of resources.
- Conduct regular audits to identify and mitigate data quality issues and improve data management processes.
- Maintain knowledge of new technologies, trends, and regulations in the field of clinical data management and apply this knowledge to enhance existing processes and systems.
- 10-15 years of experience in clinical trial/data management and data operations.
- Minimum 4-5 years of people management (preferred) 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.
- Opportunity to work with a talented team of professionals in the field of clinical data management.
- Professional growth and development opportunities.
- Competitive salary and benefits package.
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