Project Role: Clinical Data Specialist
Work Experience: 1.5 - 4 Years
Work location: Homebased
Work Mode: Remote
Must Have Skills: Clinical data management, Veeva, Startup, Conduct and Closeout.
Job Overview
Experience & Background
- 4–6 years of hands-on Clinical Data Management experience in study start-up, study execution, and closeout activities.
- Strong exposure to Veeva EDC is highly preferred.
- Experience with eCOA and third-party data reconciliation, and SAE reconciliation (optional but beneficial).
- Ability to work independently while effectively collaborating with global teams.
Technical & Functional Skills:
- Ensure data acquisition, database design, edit check specifications, eCOA integration, and observed dataset requirements aligned with protocol objectives.
- Proficiency in tracking, monitoring, and reporting key metrics across study build, execution, and data delivery.
- Experience in data validation, discrepancy management, listings review, and QC activities. Strong understanding of integration of disparate data sources into unified datasets for analytics and decision-making.
- Therapeutic knowledge sufficient to perform high-quality data review and identify protocol-relevant trends or issues. Understanding of the technology ecosystem used for clinical data review to ensure accuracy and consistency of database deliverables.
Educational Qualifications:
- Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT).
- Minimum of 5 years of data management experience.
- Project management experience is required.
- Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
- Oncology, endocrine and/or inflammatory therapeutic area experience is preferred.
