Lead Clinical Data Manager

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.