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gcp ehr edc tmf ich-gcpπ Description
- Oversee site management and patient safety; ensure data quality and QA.
- Ensure audit readiness; support audits and follow-up actions.
- Manage trial tools, tracking, and status reports.
- Lead site start-up: feasibility, investigator recruitment, regulatory submissions.
- Negotiate budgets and site contracts with guidance from Site Contract Management.
- Conduct on-site and remote monitoring visits; prepare timely monitoring reports.
π― Requirements
- University degree in life sciences/pharmacy/health discipline or equivalent; licensed HC professional.
- 2+ years as CRA in CRO/clinical research; site management experience; travel up to 60%.
- Oncology or Cardiology monitoring experience; EDC trials and EHR experience preferred.
- Excellent communication and organizational skills; team player.
- Proficiency with computerized information systems, spreadsheets, word processing, and email.
- Fluency in English; local language for the country where position is based.
π Benefits
- Paid time off and volunteer time off
- Robust medical offerings
- Non-vested 401(k) with company match
- Paid parental leave
- Professional growth opportunities
- Work-life balance and supportive team culture
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