Lead Clinical Data Manager

MEDTEK AI; Dadri; On-site; INR 2,500,000 - 5,000,000; Full time

Benefits offered by this job

Cutting-edge projects

Flexible work environment

Growth opportunities

Job summary

Medtek Dot AI Pvt limited is seeking a Lead Clinical Data Manager to oversee data management activities across clinical trials for pharma/biotech clients. The role ensures high-quality data collection, processing, and delivery in line with regulatory standards and timelines.

The candidate will lead end-to-end data management, develop DMPs, CRFs/eCRFs, and edit checks, coordinate with Biostatistics, Clinical Operations, Medical Writing, and Regulatory teams, and ensure strict adherence to ICH-GCP

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Health Informatics, or related field.

Responsibilities

• Lead and manage end-to-end data management activities across trials.
• Develop and review DMPs, CRFs/eCRFs, edit checks, and database specs.
• Coordinate with cross-functional teams (Biostatistics, Clinical Operations, Medical Writing, Regulatory).
• Oversee database design, testing, and validation in EDC systems.
• Ensure timely database lock and quality deliverables per timelines.
• Monitor compliance with ICH-GCP, CDISC, FDA, EMA guidelines.
• Serve as primary client contact for data management activities.

Skills

GCP knowledge

CDISC SDTM

MedDRA

WHO Drug dictionaries

Attention to detail

Communication

Project management

Education

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Health Informatics, or related field

Tools

Medidata Rave

Oracle InForm

SAS

SQL

Job description

Medtek Dot AI Pvt limited is a data science consulting company supporting global Pharma and Biotech companies.

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 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:

• 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.
• 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.