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 (CDM) 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 end-to-end clinical data management activities for assigned projects.
- 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
- Performs external data reconciliation against EDC.
- Performs Reliable AE reconciliation according to SOPs and guidelines, as applicable.
- Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.

Qualifications
Education & Experience:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Health Informatics, or related field.
- 9+years of clinical data management experience in CRO, pharmaceutical, or biotech industry.
- Experienc

📌 Lead Clinical Data Manager (Uttar Pradesh)
🏢 Medtek.AI
📍 Uttar Pradesh