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Act as a SME on core business software solutions (e.g., RAVE EDC system) to provide novel end-to-end software solutions that improve, automate, and solve complex business process challenges. Lead the development of clinical study databases in the Rave EDC system according to the department SOPs, including programming complex Custom Functions in C.
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Solid computer skills, proficient in MS Word and Excel; preferred experience using CTMS, EDC, or financial systems. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
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Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). ICON plc is a world-leading healthcare intelligence and clinical research organization.
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Proficient in FDA, GCP, and ICH guidelines, with solid expertise in EDC systems, data management functions, and ideally, CDISC standards. Proficient in FDA, GCP, and ICH guidelines, with solid expertise in EDC systems, data management functions, and ideally, CDISC standards.
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Prior experience processing and shipping biological samples a plus Prior EKG and centrifuge experience Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders Prior Electronic Data Capture (eDC) data entry skills.
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Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing) Responsible for working with database build vendor to develop new EDC databases and subsequent revisions.
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Manage contracts with Electronic Data Capture (EDC) and Interactive Response Technology (IRT) vendors for clinical trials. PMP Certification or Lean Six Sigma Green Belt desired. Manage contracts with Electronic Data Capture (EDC) and Interactive Response Technology (IRT) vendors for clinical trials.
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Qualifications include 10+ years' experience in clinical research and management, proficiency with EDC platforms, experience in Good Clinical Practice, knowledge of veterinary medical terminology, willingness to travel as needed, exceptional skills in speaking and writing, proven ability in a fast-paced, high-pressure environment, aptitude for working independently and with a team, and fluency in U.S. regulatory requirements.
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