Clinical Data Manager

JD FOR CLINICAL DATA MANAGER

• 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

• 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.