Business Analyst - Clinical Trials
Nexwave
Position: Business Analyst – Clinical Trials
Domain: Pharma / Clinical Research (Mandatory)
Location: Remote
Rate: $57/hr on C2C/1099 (OR) $50/hr on w2 (Max - No rate Negotiation)
Job Description:
Seeking an experienced Business Analyst with strong Pharma/Clinical Trials domain experience to support clinical trial technology
The ideal candidate should have experience gathering and analyzing clinical study protocols, defining study requirements, designing data collection forms, visit schedules, edit checks, validation rules, and clinical workflows.
Required Skills:
- Strong Pharma / Clinical Research / Clinical Trials domain experience.
- Hands-on BA experience with eSource, DDC, eCOA, ePRO, or eClinical solutions.
- Clinical study protocol analysis, CRF specifications, study builds, and data capture workflows.
- Experience creating BRDs, functional specifications, user stories, workflow diagrams, and traceability matrices.
- Knowledge of GCP, FDA 21 CFR Part 11, GxP compliance, and UAT/validation.
- Experience working with sponsors, CROs, Clinical Operations, Data Management, QA, and technical teams.
- Knowledge of CDISC/SDTM standards and decentralized clinical trials (DCT) is preferred.
Stephen
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