We are currently seeking a Lead Clinical Data Manager to join a global clinical development team. This is a high-level contract opportunity ideal for an experienced professional capable of taking independent ownership of data management activities.

You will be joining a well-established team working on a significant, long-term obesity trial. This position focuses heavily on the specification and oversight phases rather than just the build. You will be instrumental in supervising data management activities and ensuring the integrity of clinical trial data within the RAVE environment.

Key responsibilities

• Implementation, monitoring, and supervision of data management activities within assigned clinical trials.
• Design, create, validate, review, approve, and maintain data management tool specifications. This includes eCRFs and their set-up in the EDC system, time and events schedules, eCRF entry guidelines, edit checks, data review plans, and data management plans.
• Provision of adequate sponsor oversight of data management CROs or external data providers.
• Creation and execution of data quality checks throughout study conduct.
• Filing and archiving of trial documentation.

Skills and experience

• At least 6 to 10 years of experience in clinical data management, gained within either a pharmaceutical or CRO environment, with a proven track record of delivering quality data.
• Strong experience with Medidata RAVE is highly preferred for this specific project.
• Knowledge in and experience with the use of data collection tools, data review tools, and data standardisation methods.
• Experience working in agile teams or acting as a product owner is a distinct advantage.
• Excellent communication skills with fluency in English, both speaking and writing, is essential.
• Deep understanding of CDISC standards and SAS is beneficial.
• Ability to make independent decisions and solve complex problems within a global team structure.

You will need to be based in either the UK, Italy, France, Spain, Ireland or Hungary for this role.