Clinical Data Manager
- Medtek Dot Ai
- 5 - 9 years
- Noida, Gurugram
- 15 hours ago
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Job Description
JD FOR 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 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
Qualifications
Education & Experience:
- Bachelors or Masters degree in Life Sciences, Pharmacy, Health Informatics, or related field.
- 5-9 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.
- 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.
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Healthcare & Life SciencesRole Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: Medtek Dot AiLocation(s): Noida, Gurugram
Keyskills: Medidata Rave Clinical Data Management EDC Oracle Clinical Clinical Trials
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Medtek Dot Ai
Medtek is a data science driven company to support faster drug development and healthcare solutions.We support growing Biotech and Pharma companies. Assist clients with Data Technologies, Data Analysis, Data Mining, CDISC, Visualisation and Regulatory reporting.
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