BDC Study Designer - CPS

FTLEE Fortrea Clinical Research Unit Ltd; Leeds; Ibrido; GBP 45.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Office-based or home-based in listed/乡

Competitive compensation packages

Work-life balance and flexible working

Comprehensive onboarding and training

Continued professional development

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

EDC systems

GCP/ICH knowledge

Regulatory compliance

Clinical research process

Formazione

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

Descrizione del lavoro

Bedside Data Capture (BDC) Study Designer

Bedside Data Capture (BDC) Study Designer Joining Fortrea’s Bedside Data Capture (BDC) team offers an exciting opportunity to contribute to the successful delivery of Phase I clinical studies through innovative electronic data capture solutions. You will work within a highly collaborative, fast-paced environment alongside Clinical Research Units, Biometrics, Clinical Operations, IT teams, and Project Managers to ensure accurate and efficient study setup and execution. This role is ideal for professionals with experience in clinical research and electronic data capture systems who enjoy translating study protocols into practical data collection solutions. As a BDC Study Configuration Specialist, you will play a critical role in configuring studies, supporting data collection processes, maintaining study documentation, and ensuring the highest standards of quality and compliance throughout the study lifecycle.

What you can expect from us

• Office based or home based in the listed countries
• Rewarding and meaningful work in an established, diverse, highly respected global company
• Highly competitive compensation packages, including country-specific benefits and wellbeing programs
• A genuine work-life balance with flexibility in working arrangements
• Comprehensive onboarding and training supported by experienced colleagues and mentors
• Opportunities for continuous learning, professional development and career progression

Your 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.

Your profile

• Bachelor’s degree in Life Sciences, Clinical Research, Information Technology or another related scientific or technical discipline preferred.
• 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.
• Strong collaboration skills with the ability to work effectively across cross-functional teams.
• Experience in a regulated environment and knowledge of medical terminology would be advantageous.
• Ability to work independently while maintaining a high level of attention to detail and quality.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

For more information about Fortrea, visit Fortrea.

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