We are seeking an experienced Clinical Data Manager (CDM) / Lead Clinical Data Manager to join our growing clinical data management team. The ideal candidate will have a strong background in end-to-end data management , EDC systems (preferably Medidata Rave, Veeva, InForm /CD or similar) , and experience leading or mentoring data management teams. This role will be office- based in Gurugram , with close collaboration with leadership and cross-functional teams to ensure data integrity, compliance, and quality throughout clinical studies. aEUR<
What youaEUR(TM)ll do
Manage and oversee all aspects of clinical data management (CDM) activities for assigned clinical studies. aEUR<
Develop and review Data Management Plans (DMPs) , CRF designs , edit checks , and data validation plans . aEUR<
Ensure timely data cleaning, Query Management, Data review, Data/SAE Reconciliation, Database lock, and delivery of high-quality datasets . aEUR<
Expertise in creating and maintaining the essential documents in eTMF or equivalent documents repositories in compliance with good documentation practices. aEUR<
Collaborate closely with cross-functional teams, including database developer, Report Programmers, biostatistics and clinical operations. aEUR<
Serve as a subject matter expert (SME) for assigned EDC systems (e.g., Medidata Rave, Veeva, InForm /CD or similar) . aEUR<
Perform data review, discrepancy management, and validation per study timelines and SOPs. aEUR<
Coordinate with vendors, CROs, and internal stakeholders for database development and testing. aEUR<
Provide thought leadership and contribute to process improvements, automation, and standardization initiatives. aEUR<
Mentor junior data managers and contribute to team development activities. aEUR<
Must have
8-12 years of relevant experience in Clinical Data Management in the pharmaceutical, CRO, or biotech industry. aEUR<
Strong knowledge of EDC systems (Medidata Rave preferred). aEUR<
Experience with metadata management, CRF annotation , and data validation . aEUR<
Deep understanding of CDISC/CDASH standards , GCP , and clinical data workflows . aEUR<
Excellent communication and interpersonal skills to collaborate with cross-functional teams. aEUR<
Proven ability to handle multiple projects , meet deadlines, and maintain data quality. aEUR<
Experience leading data management activities or mentoring team members is highly desirable.
Educational Background
Minimum qualification: BacheloraEUR(TM)s degree (10+2+3) in Life Sciences, Clinical Research, Microbiology, Biotechnology, or a related discipline. aEUR<
MasteraEUR(TM)s degree in Clinical Research, Life Sciences, Biomedical Science, or any other related scientific field is preferred.
aEUR
Beware of fraud agents! do not pay money to get a job
MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.