Lead Clinical Data Manager

Medtek Dot Ai; Dadri; Hybrid; INR 2,500,000 - 4,500,000; Full time

Benefits offered by this job

Cutting-edge projects

Growth-focused environment

Job summary

Medtek Dot AI Pvt Limited is seeking a Lead Clinical Data Manager to oversee data management across trials for pharma and biotech clients. You will ensure high-quality data collection, processing, and delivery in line with regulatory standards and timelines.

The role requires 9+ years in clinical data management, expertise with EDC systems like Medidata Rave and Oracle InForm, and strong leadership and communication skills.

Qualifications

• 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 (Medidata Rave, Oracle InForm).
• 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.

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.

Skills

Clinical trials

GCP

CDISC SDTM

MedDRA

WHO dictionaries

Attention to detail

Problem solving

Communication

Organizational skills

Project management

Independent work

Team collaboration

Education

Bachelor’s or Master’s in Life Sciences/Pharmacy/Health Informatics

Tools

Medidata Rave

Oracle InForm

Job description

JD FOR LEAD CLINICAL DATA MANAGER
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.