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 LeadClinical 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.