PURPOSE
Serve as the EDC System Designer for the build team, and produce accurate and complete specifications documents.
RESPONSIBILITIES
- Development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understand Quintiles EDC processes and the requirements on the design for reporting and study management.
- Advise and provide justification for design decisions to Principal Programmer and at Design Meeting.
- Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency.
- This role will eventually (3-6 months after starting) be responsible for providing a draft Edit Check Specification to the DTL.
- Requires good communication skills and this role will work closely with the Study DTL and Principal Programmer.
- Requires a technically logical thinker to resolve questions and issues with the Principal Programmer, DTL and VTL. This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system.
EDUCATION
- Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field.
- 3 years direct Data Management experience, including 1 or more years as a CDM project lead. Equivalent combination of education, training and experience.
- Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com