Clinical Data Manager at Cepheid
Looking for a Clinical Data Manager with a global diagnostics leader? Cepheid Careers is hiring an experienced professional for its Clinical Affairs team in Bangalore. If you’re searching for Clinical Data Management Jobs, this opportunity allows you to work on pre-market and post-market IVD clinical trials, ensuring data integrity, regulatory compliance, and high-quality clinical research while collaborating with global cross-functional teams.
About Cephid:
Cepheid, a Danaher operating company, is a global leader in molecular diagnostics dedicated to improving healthcare through innovative diagnostic solutions. By combining cutting-edge technology with scientific expertise, Cepheid develops products that enable faster and more accurate disease detection. Through Cepheid Careers, professionals work on impactful healthcare innovations while enjoying a collaborative culture, career development opportunities, and comprehensive employee benefits.
Job Details:
- Job Position: Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs
- Location: Bangalore, Karnataka, India
- Employment Type: Full-Time
- Reference Number: R1315385
Job Description:
The Clinical Data Manager is responsible for ensuring the accuracy, completeness and integrity of data collected during IVD clinical trials. The CDM develops the clinical data management plan for pre-market and post-market clinical trials and ensures timely execution of these plans throughout the lifecycle of the study. The role involves close collaboration with clinical teams, study projects, and biostatistics to support database development, validation, and data review processes.
Key Responsibilities:
- Develop clinical study data management plans and provide clinical data management support for clinical teams, study projects, and biostatistics.
- Execute data management plans across the full study lifecycle.
- Develop case report forms (or eCRF), clinical trial data specifications, and EDC database specifications.
- Define user requirements, edit rules/checks, query logic and data validations.
- Create data listings and perform summary table validation.
- Process data transfers in preparation for statistical review and/or data management audit.
- Execute database lock, freeze, close-out audits and archival activities for clinical trials.
- Manage external data transfers, including reconciliation, dataset preparation, and audit readiness activities.
Educational Requirements for a Clinical Data Manager Job:
- Bachelor’s or master’s degree in health care area
- 5+ years of experience in developing and executing clinical data management procedures
- Thorough knowledge of clinical research
Required Skills for a Clinical Data Manager Job:
- Experience with database lock, freeze, close-out audits and archival activities
- Management of external data transfers and data transfer agreements
- Proficiency in generating data listings and validating summary tables
- User acceptance testing following database upgrades or migrations
- EDC user management across clinical trials
- Creation of user guides for EDC training
- Understanding of data system compliance guidelines from regulatory authorities
- Demonstrated ability to explain complex or sensitive information to diverse audiences, including senior leaders
