EDC Study Designer for Phase I Trials

Fortrea Development India Private Limited; United States; Hybrid; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Fortrea is seeking a Bedside Data Capture (BDC) Study Designer to translate study protocols into efficient data collection configurations. You will work with Clinical Operations, Biometrics and IT to ensure accurate study setup and timely delivery in a fast‑paced environment.

You will configure data capture forms, perform post‑go‑live updates, and maintain essential study documentation while upholding GCP and 21 CFR Part 11 standards.

Qualifikationen

• Bachelor's degree in Life Sciences, Clinical Research, Information Technology or related field preferred.
• Minimum 3–4 years' experience in a clinical research environment (Phase I experience preferred).
• Strong knowledge of EDC systems and clinical trial processes.
• Working knowledge of GCP, ICH Guidelines and 21 CFR Part 11 requirements.
• Experience with clinical source documentation and data collection workflows.
• Excellent organizational and cross‑functional collaboration skills.

Aufgaben

• Configure studies in the Bedside Data Capture (BDC) system per protocol and timelines.
• Perform post go‑live study updates and ongoing maintenance.
• Translate study design requirements into electronic data collection forms (CRF and non‑CRF).
• Collaborate with Clinical Operations, Biometrics, PMs, CRAs and IT to ensure delivery.
• Provide protocol feedback from a BDC setup perspective for efficient execution.
• Support study documentation and eTMF filing.
• Ensure compliance with regulatory requirements (GCP, ICH, 21 CFR Part 11).
• Contribute to audits, inspections and data requests as needed.
• Identify study risks and assist with mitigation activities.
• Support UAT activities and system validation tasks.

Kenntnisse

EDC systems

Cross-functional collaboration

Regulatory compliance

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences/Clinical Research/IT

Tools

eTMF systems

Jobbeschreibung

Fortrea is seeking a Bedside Data Capture (BDC) Study Designer to translate study protocols into efficient data collection configurations. You will work with Clinical Operations, Biometrics and IT to ensure accurate study setup and timely delivery in a fast‑paced environment.

You will configure data capture forms, perform post‑go‑live updates, and maintain essential study documentation while upholding GCP and 21 CFR Part 11 standards.