Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs
Danaher / Cepheid
Bengaluru, India
Onsite
Bachelor's or master's degree in science
5+ years clinical data management experience
Developing clinical study data management plans
Cepheid, a Danaher operating company, is seeking a Lead Clinical Data Manager in Bengaluru, India, to oversee the accuracy and integrity of data in IVD clinical trials. The role involves developing clinical data management plans, managing data throughout the study lifecycle, and ensuring compliance with regulatory guidelines
Job Summary
The Lead Clinical Data Manager is responsible for ensuring the accuracy, completeness, and integrity of data collected during IVD clinical trials.
This role involves developing clinical data management plans for pre-market and post-market studies and executing them throughout the full lifecycle.
Cepheid offers comprehensive benefit programs including health care and paid time off to support life beyond the job.
Matching Summary
Match Score: 85
Cepheid, a Danaher operating company, is seeking a Lead Clinical Data Manager in Bengaluru, India, to oversee the accuracy and integrity of data in IVD clinical trials. The role involves developing clinical data management plans, managing data throughout the study lifecycle, and ensuring compliance with regulatory guidelines.
Skills & Requirements
Must-have
Bachelor's or master's degree in science
5+ years clinical data management experience
Developing clinical study data management plans
Creating case report forms and EDC specifications
Executing database lock, freeze, and close-out audits
Nice-to-have
Experience in in-vitro diagnostics clinical research
Pathology and Companion Diagnostics background
Ability to explain complex information to leaders
Continuous improvement mindset within business
Excellent organizational skills and ambition
Key Requirements
Bachelor's or master's degree in science or healthcare
5+ years of experience in clinical data management procedures
Proficiency with EDC user management and UAT
Knowledge of regulatory authority guidelines for data compliance