
Medtek.AI is a data science-driven company based in India, specializing in accelerating drug development and healthcare solutions for the pharmaceutical and biotechnology industries. They offer a…

Medtek.AI is a data science-driven company based in India, specializing in accelerating drug development and healthcare solutions for the pharmaceutical and biotechnology industries. They offer a…
Medtek Dot AI Pvt limited is a data science consulting company supporting global Pharma and Biotech companies.
Our mission is to help “Unlock insights and drive innovations” using the data collected. We are a team of Biostatistician, Data Managers, Programmer s, Engineers and AI developers .
Job Summary
We are seeking an experienced and detail-oriented Lead Clinical Data Manager to oversee data management activities across clinical trials for pharmaceutical and biotech clients. The ideal candidate will ensure high-quality clinical data is collected, processed, and delivered in compliance with regulatory standards and timelines.
Key Responsibilities
· Lead and Manage the assigned Phase1/2/3 Clinical study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality.
· Review EDC design, UAT, study metrics and data quality report
· End-to-End CDM expertise
· Strong knowledge of Rave EDC
· Project Management (Min 5 yrs)
· Vendor & Stakeholder Management
· Develop and review data management plans (DMP), CRFs/eCRFs, edit checks, and database specifications.
· Coordinate with cross-functional teams including Biostatistics, Clinical Operations, Medical Writing, and Regulatory Affairs.
· Oversee database design, testing, and validation in EDC systems (e.g., Medidata Rave, Oracle InForm, or similar).
· Perform ongoing data review, discrepancy management, query generation and resolution.
· Ensure timely database lock, database freeze, and quality deliverables in accordance with project timelines.
· Monitor compliance with ICH-GCP, CDISC, FDA, EMA, and other regulatory guidelines.
· Act as primary point of contact for clients regarding data management activities.
· Reconcile Safety and Efficacy Data
Qualifications
Education & Experience:
Skills:
Preferred Qualifications
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