Our client is a small CRO which has serviced trials across the globe, they have been established for 30+ years and covering all therapy areas. The have started a new venture recently and specializing in oncology. They are looking for someone based in the United States East Coast, they are offering a flexibility with working from home. It is an exciting time to join the company as they have a great pipeline for the future.
- Provide data management input to relevant strategic study documents (e.g. study protocol) and vendor contracts.
- Create or ensure development of relevant Data Management documentation (i.e. Data Management Plan).
- Ensure high quality data management support for projects through the evaluation of CRO suppliers and provide input into outsourcing strategy and processes.
- Validate or review study data in CDISC format using available tools according to client standards
- Coordinate data deliverables and adherence to relevant government guidelines in preparation for submission.
- Ensure new data system(s) and new technical tools/equipment(s) to be used are in compliance by following the established guidelines of national and international regulatory authorities.
- Work as a member of the Clinical Team to establish, communicate and deliver on a clinical data handling strategy and plan.
- Experience of drug development including computer applications, database systems and clinical development/clinical data management.
- Familiar with CDISC conventions, i.e. SDTM and ADaM models and controlled terminology, and experience implementing and using these models.
- Excellent skills in writing Data Management specific documents (e.g. Reviewers Guide, User Requirement Specification and Data Management Plans).
- Demonstrated project leadership experience.
- Demonstrated ability to find innovative approaches.
- Strong individual initiative and organizational skill.
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.