Note: The job is a remote job and is open to candidates in USA. Trident Consulting is seeking a Clinical Data Manager to support end-to-end clinical data management for a client. The role manages clinical data activities from study start-up through closeout, including EDC systems, database management, data cleaning, clinical data review, reconciliation, documentation, and cross-functional collaboration.
Responsibilities
- Manage clinical data management activities from study start-up through closeout
- Develop and maintain Data Management documentation (DMPs, CRF Guidelines, Edit Check Specifications, etc.)
- Oversee EDC systems, database management, UAT testing, and data cleaning activities
- Review clinical data, resolve queries, and ensure data quality and regulatory compliance
- Support data reconciliation, medical coding, AE/SAE reconciliation, and external data review
- Collaborate with Clinical, Programming, Regulatory, and Study teams
- Generate study metrics, reports, and maintain audit-ready documentation
- Contribute to SOPs, process improvements, and training materials
Skills
- • 2–5 years of Clinical Data Management experience
- • Experience in Pharmaceutical, Biotechnology, Medical Device, or CRO environments
- • Hands-on experience with EDC systems (Medidata RAVE, Oracle Inform, or similar)
- • Strong knowledge of FDA, ICH, CDISC (SDTM/CDASH), and clinical data management regulations
- • Experience with data cleaning, query management, reconciliation, and database management
- • Strong project coordination, analytical, and communication skills
- • Experience with SAS, SQL, or Excel is a plus
- • Bachelor's degree in Biological Sciences, Nursing, or a related healthcare field preferred
- • Ophthalmology clinical research experience
- • Medical device clinical study experience
Company Overview
Company H1B Sponsorship