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/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

Qualifications

Education & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Health Informatics, or related field.
• 10+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.