Lead clinical data manager

MEDTEK AI · Uttar pradesh, India

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/e CRFs, 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 In Form, 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