ICON plc is looking for a Principal Clinical Data Science Lead to manage clinical data science teams, studies, and programs of studies, ensuring project objectives are met within budget, timelines, and quality standards, particularly within the Early Phase clinical development services.
Requirements
- 6+ years of clinical data management experience (in a Clinical Research Organization or Pharmaceutical company)
- 3+ years of experience leading studies with key responsibilities for study set-up and close-out tasks
- Experience with Rave strongly preferred, but must have experience with at least one of ICON’s preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
- Highly computer literate, including strong Microsoft Office skills
Responsibilities
- Manage a number of fast-moving early phase studies or programs of studies to ensure project objectives are met within budget, to agreed timelines, and to a high level of quality
- Manage a global team of clinical data management resources
- Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents and will be responsible for the maintenance, cleaning, and lock of the EDC study databases
- Review the project contract in order to ensure that any out-of-scope work is managed promptly and efficiently
- Manage the overall project budget throughout the life cycle of the project, taking overall responsibility for cost control, timelines, and project quality
- Negotiate with clients and/or external customers/departments in relations to timelines and key deliverables
- Work with Clinical Operations, Biostatistics, SAS Programming, Medical Writing, and Quality Assurance to ensure that data collected during trials is managed according to corporate standards and meets regulatory guidelines for data integrity
Other
- Travel (approximately 15%) domestic and/or international
- Excellent communication and interpersonal skills
- Strong client relationship management skills
- Excellent organizational and planning skills as well as a demonstrated aptitude for project management
- Bachelors degree or local equivalent in a scientific field and/or equivalent experience
