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 (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:
- 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.
