Job Title:
Clinical Data Manager II
Location:
Bangalore, Karnataka, India
Chennai, Tamil Nadu, India
Job Type:
Regular – Full-Time
Division:
Precision for Medicine – Clinical Solutions
Requisition Number:
5655
Position Summary:
The Clinical Data Manager II is responsible for leading and managing the data management process across the life cycle of assigned clinical trials—from startup through database lock. This includes database development, CRF design, UAT testing, query management, coding, and overall data quality oversight. The role may also contribute to SOP development, client interaction, and mentoring of junior staff.
Key Responsibilities:
Serve as the Lead Data Manager or key contributor on clinical trials, managing all data-related aspects.
Input into timelines and resource planning; ensure adherence to quality and deadlines.
Develop CRF specifications and manage stakeholder feedback.
Oversee or perform clinical database builds and UAT testing.
Review clinical data per Data Management Plan and perform line listing data checks.
Maintain and version data management documentation for the Trial Master File.
Specify and implement edit checks and data validation procedures.
Train internal teams and site personnel on CRFs, EDC, and data workflows.
Liaise with vendors to coordinate external data and ensure deliverable quality.
Perform and oversee medical coding and SAE/AE reconciliation.
Assist in bid defenses, RFP responses, and protocol/SAP/CSR reviews.
May contribute to SAS programming/QC, SOP creation, and process improvements.
Present training, demos, and attend client-facing meetings.
May require some travel.
Qualifications:
Minimum Required:
Bachelor’s degree or relevant combination of education and experience.
5+ years of Clinical Data Management experience.
Fluent English language proficiency (written and spoken).
Other Required:
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
Strong understanding of clinical research and CDMS usage.
Excellent communication, organization, and multitasking skills.
Broad knowledge of clinical development processes and data quality best practices.
Preferred:
Familiarity with MedDRA and WHO Drug coding dictionaries.
Working knowledge of CDISC standards (CDASH, SDTM, ADaM).
Therapeutic area experience in Oncology and/or Orphan Drugs.
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