Clinical Database Manager

4 days ago

Gurugram Gurugram India ProcDNA Full time

Job Description What We Are Looking For We are seeking an experienced Clinical Data Manager (CDM) / Lead Clinical Data Manager to joinour growing clinical data management team. The ideal candidate will have a strong background inend-to-end data management, EDC systems (preferably Medidata Rave, Veeva, InForm/CD orsimilar), 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 ensuredata integrity, compliance, and quality throughout clinical studies. What You'll Do - Manage and oversee all aspects of clinical data management (CDM) activities for assigned clinicalstudies. - Develop and review Data Management Plans (DMPs), CRF designs, edit checks, and datavalidation plans. - Ensure timely data cleaning, Query Management, Data review, Data/SAE Reconciliation,Database lock, and delivery of high-quality datasets. - Expertise in creating and maintaining the essential documents in eTMF or equivalent documentsrepositories in compliance with good documentation practices. - Collaborate closely with cross-functional teams, including database developer, Report Programmers,biostatistics and clinical operations. - Serve as a subject matter expert (SME) for assigned EDC systems (e.g., Medidata Rave, Veeva,InForm/CD or similar). - Perform data review, discrepancy management, and validation per study timelines and SOPs. - Coordinate with vendors, CROs, and internal stakeholders for database development and testing. - Provide thought leadership and contribute to process improvements, automation, andstandardization initiatives. - Mentor junior data managers and contribute to team development activities. Must have - 812 years of relevant experience in Clinical Data Management in the pharmaceutical, CRO, orbiotech industry. - Strong knowledge of EDC systems (Medidata Rave preferred). - Experience with metadata management, CRF annotation, and data validation. - Deep understanding of CDISC/CDASH standards, GCP, and clinical data workflows. - Excellent communication and interpersonal skills to collaborate with cross-functional teams. - Proven ability to handle multiple projects, meet deadlines, and maintain data quality. - Experience leading data management activities or mentoring team members is highly desirable. Educational Background - Minimum qualification: Bachelor's degree (10+2+3) in Life Sciences, Clinical Research,Microbiology, Biotechnology, or a related discipline. - Master's degree in Clinical Research, Life Sciences, Biomedical Science, or any other relatedscientific field is preferred. Skills: clinical data management,edc,subject matter experts

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