Clinical Trial Posting Expert

Major Responsibilities

• Provide up to date and consistent Clinical Trial Posting data on all required company owned and public websites, with special focus on results posting processes
• Contribute to continuous monitoring for changing and new Clinical Trial Posting requirements to keep the Global Development Management up to date and to adjust and update the global strategy, and internal rules and processes accordingly
• Perform and supervise quality control of publicly disclosed clinical trial information according to the QA process established
• Check consistency of disclosed information for a study, i.e. consistency of disclosed information on different internet sites and of registry and results posting information for the same study
• Check postings for inappropriate wording, especially for promotional language
• Check compliance to internal disclosure process and to external legislations and obligations
• Collection / Supervision of collection of the necessary data for public disclosure of clinical trial information within BHC: design forms/templates, request information, track responses, disclose information
• Provide up to date and consistent Clinical Trial Posting data on all required company owned and public websites

Education, Know How and Experience

• Graduate in Medicine / Natural Sciences or equivalent long-term professional experience
• Min. 2 – 3 years experience in clinical development with significant experience related to clinical trials
• 1-2 year working experience as ‘Senior Clinical Trial Posting Associate’, or equivalent Webposting working experience
• Good experience of developing and delivering presentations and publications in English
• Good understanding of ICH/GCP regulations
• Solid understanding of global legislations, regulations and guidelines