BDC Study Designer - Remote Data Capture Innovator

FTLEE Fortrea Clinical Research Unit Ltd; Leeds; Hybrid; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Office-based or home-based in listed/乡

Competitive compensation packages

Work-life balance and flexible working

Comprehensive onboarding and training

Continued professional development

Job summary

Fortrea is seeking a Bedside Data Capture (BDC) Study Designer to join the BDC team and contribute to Phase I study delivery via electronic data capture systems.

The role involves configuring studies, translating study design into data collection forms, and ensuring QA and regulatory compliance. Office-based or home-based options exist with a focus on quality and collaboration across Clinical Operations, Biometrics, IT and project teams.

Qualifications

• Minimum 3-4 years of experience in a clinical research environment, preferably with exposure to Phase I studies.
• Understanding of Electronic Data Capture (EDC) systems and the clinical trial process.
• Working knowledge of GCP, ICH Guidelines and 21 CFR Part 11 requirements.
• Experience working with clinical source documentation and data collection workflows.
• Strong organizational skills with the ability to manage multiple priorities in a deadline-driven environment.

Responsibilities

• Configure studies within the Bedside Data Capture (BDC) system, including recruitment, screening and on-study components, ensuring alignment with study protocols and timelines.
• Perform post go-live study updates and system maintenance activities to support ongoing study requirements.
• Review and interpret clinical study protocols and translate study design requirements into electronic data collection forms, including both CRF and non-CRF fields.
• Collaborate closely with Clinical Operations, Biometrics, Project Managers, CRAs, IT teams and study staff to ensure successful study delivery.
• Participate in protocol reviews and provide feedback from a BDC study set-up perspective to support efficient study execution.
• Support study documentation activities and ensure required documents are available and maintained for inclusion in the electronic Trial Master File (eTMF).
• Ensure compliance with applicable regulatory requirements, GCP, ICH guidelines, SOPs and Good Documentation Practices.
• Contribute to internal and external audits, inspections and data requests as required.
• Identify study-specific risks, assess their impact and support mitigation activities.
• Support User Acceptance Testing (UAT) activities and assist with system validation tasks.

Skills

EDC systems

GCP/ICH knowledge

Regulatory compliance

Clinical research process

Education

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

Job description

Fortrea is seeking a Bedside Data Capture (BDC) Study Designer to join the BDC team and contribute to Phase I study delivery via electronic data capture systems.

The role involves configuring studies, translating study design into data collection forms, and ensuring QA and regulatory compliance. Office-based or home-based options exist with a focus on quality and collaboration across Clinical Operations, Biometrics, IT and project teams.