Lead Clinical Data Manager

Lead Clinical Data Manager

Company: Medtek Dot Ai

Job Location: Uttar Pradesh, India

Employment Type: Full-time

Experience Required: 9+ years

Salary: 25L45L a year

JD FOR LEAD CLINICAL DATA MANAGER

Company Description

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 Serious 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

Bachelors or Masters degree in Life Sciences, Pharmacy, Health Informatics, or related field.

9+years of clinical data management experience in CRO, pharmaceutical, or biotech industry.

Experience with EDC systems (e.g., Medidata Rave, Oracle InForm).

Skills

Strong understanding of clinical trial processes and GCP.

Knowledge of CDISC standards (SDTM), MedDRA, and WHO Drug dictionaries.

Excellent attention to detail and problem-solving skills.

Strong communication, organizational, and project management skills.

Ability to work independently and in a fast-paced, team-oriented environment.

Preferred Qualifications

Experience with oncology, rare disease, or other complex therapeutic areas.

Familiarity with programming languages such as SAS or SQL is a plus.

CDM certification (e.g., CCDM from SCDM) is an advantage.

What We Offer

Opportunity to work on cutting-edge clinical research projects.

Collaborative, flexible, and growth-oriented work environment. .