Labcorp Drug Development are seeking a BDC Study Designer to join our Clinical Pharmacology Services division. This position is fully remote and can be home-based anywhere in the United States. The BDC Study Designer is responsible for the creation of studies and all required components within the Bedside Data Capture (BDC) system based on the study protocol and timelines, performing any post go-live updates within the BDC system and working in close conjunction with other BDC staff, Project Managers, Clinic Study Teams, Biometrics, CRAs, IT Staff, and IT Help Desk.
Your main duties will include but not be restricted to:
Effectively configure studies within the electronic data capture system, including recruitment, screening, and on-study components.
Assignment to complex studies / projects or ownership of a portfolio of studies.
Perform any post go-live updates within the BDC system
Understands electronic data capture system and connection to electronic case report form (eCRF).
Maintains familiarity with routine study procedure forms and becomes familiar with specialized study procedure forms.
Thoroughly understands system user roles and how they differ.
Understands general logistics for data collection at the CRU.
Read and understand study protocols and Labcorp SOPs as background to enable accurate translation of the study design into data collection forms containing both CRF and non-CRF fields within the electronic data capture system.
Provide feedback on draft protocols from a BDC study setup perspective.
Communicate and collaborate with internal and external teams to meet study timelines.
Maintain an understanding of applicable regulatory requirements.
Provide data and expertise as required to support internal and external requests including audit initiatives.
Ensure internal standards and client expectations are met or exceeded in terms of quality and timeliness.
Act as a subject matter expert for any / all modules within the BDC system.
University/College Degree (preferably a Bachelor degree) in a technical or Life Sciences focus area.
Equivalent experience within clinical research environment of 5+ years may be substituted for education requirements.
Basic understanding of coding logic.
Technical understanding and working knowledge of electronic data capture software applications.
Strong analytical and interpersonal skills and ability to grasp complex systems, processes, and system improvements with urgency.
Technical understanding and working knowledge of clinical protocol source data documentation.
Understanding of simple logic, links code, and algebra.
Knowledge of end-to-end clinical trial management.
At least 4 to 5 years of experience working in a clinical research environment with an emphasis in Phase I.
Understanding of Electronic Data Capture (EDC) and the clinical trial process.
Experience interpreting Clinical Study Protocols.
Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
Strong MS / Office skills in particular with Excel and Word.
Knowledge of medical terminology preferred.
Prior experience performing complex technical activities.
Good computer skills with good working knowledge of a range of software package.
Minimum 2 years work experience in a regulated (FDA, EPA, etc.) environment.
Experience with Labcorp CRU operations.
Get ready to redefine what's possible and discover your extraordinary potential at Labcorp Drug Development. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us and discover why Labcorp Drug Development has been named by Fortune® Magazine as one of the World's Most Admired Companies 2022 for the fourth consecutive year, by FORBES as one of the World's Best Employers 2021 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.
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