About the Role: The Clinical Data Manager will oversee end-to-end data management activities for clinical trials, ensuring the accuracy, completeness, and integrity of clinical data. This role involves managing database setup, data validation, and database lock processes, while coordinating with cross-functional teams including clinical operations, biostatistics, and medical reviewers. The Clinical Data Manager will ensure all activities comply with sponsor requirements, regulatory standards, and company SOPs.
Responsibilities:
- Lead the design, setup, and management of clinical trial databases.
- Develop and review Case Report Forms (CRFs), Data Management Plans (DMPs), and edit check specifications.
- Oversee data entry, cleaning, validation, and database locking processes.
- Ensure data quality and integrity in compliance with GCP, CDISC, and regulatory standards.
- Collaborate with biostatistics, medical, and project teams to ensure smooth data flow.
- Generate and review data listings, reports, and documentation for internal and regulatory audits.
- Manage timelines, deliverables, and risk assessments for data management activities.
Qualifications:
- Bachelor’s/Master’s degree in life sciences, health sciences, computer sciences, or a related field.
- 4–6 years of experience in clinical data management.
- At least 2–3 years in a Clinical Data Manager role.
- Proficiency in Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
- Strong knowledge of GCP, CDISC, and regulatory requirements.
- Excellent communication, problem-solving, and project management skills.
Application Process: Interested candidates should submit their resume and a cover letter detailing their relevant experience and qualifications.