Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs

Danaher Corp

Bengaluru, India
On-site
5+ years clinical data management experience
Developing clinical study data management plans
Executing database lock and close-out audits
Danaher Corp, through its operating company Cepheid, is seeking a Lead Clinical Data Manager to oversee data integrity and management during IVD clinical trials in Bengaluru, India. The ideal candidate will have extensive experience in clinical data management and a solid understanding of regulatory compliance within the life sciences sector

Job Summary

  • The Lead Clinical Data Manager ensures the accuracy, completeness, and integrity of data collected during IVD clinical trials.
  • This role involves developing clinical data management plans and executing them throughout the full lifecycle of pre-market and post-market studies.
  • Cepheid offers comprehensive benefit programs that contribute to life beyond the job while partnering with customers globally to solve complex challenges.

Matching Summary

Match Score: 85

Danaher Corp, through its operating company Cepheid, is seeking a Lead Clinical Data Manager to oversee data integrity and management during IVD clinical trials in Bengaluru, India. The ideal candidate will have extensive experience in clinical data management and a solid understanding of regulatory compliance within the life sciences sector.

Skills & Requirements

Must-have

  • 5+ years clinical data management experience
  • Developing clinical study data management plans
  • Executing database lock and close-out audits
  • Creating case report forms and EDC specifications
  • Managing external data transfers and validations

Nice-to-have

  • Experience in in-vitro diagnostics research
  • Companion diagnostics clinical research background
  • Ability to explain complex information to leaders
  • Ambition for continuous improvement
  • Excellent organizational skills

Key Requirements

  • Bachelor's or master's degree in science or health care
  • 5+ years experience in clinical data management procedures
  • Proficiency with EDC user management and UAT
  • Knowledge of regulatory authority guidelines for data compliance

Work Rights

Not specified

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