Clinical Trial Disclosure Specialist
hace 3 semanas
As a Clinical Trial Disclosure Specialist, you will be responsible for managing and publicly disclosing clinical trial information into clinical trial registries and posting of clinical trial result summaries on company owned and public international websites based on internal rules and external guidelines, obligations, and legislations for the entire Bayer product portfolio, including regular updates and maintenance of the disclosed information according to internal and external requirements.
Key Responsibilities:
Collection of the necessary data for public disclosure of clinical trial information within Bayer: 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.
Formal quality control of publicly disclosed clinical trial information according to the QA process established.
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 internal rules and processes accordingly.
Requirements:
Degree in Medicine, Life Sciences, or Natural Sciences or equivalent professional experience.
Experience in clinical development with significant experience related to clinical trials, e.g., as Study Manager, CRA, or Data Manager.
Solid understanding of global legislations, regulations and guidelines.
Understanding of ICH/GCP regulations.
Solid understanding of drug development process over different stages.
Solid understanding of IT processes and Systems used in Clinical Development, especially Clinical Trial Management Systems, Document and Workflow Management Systems.
Strong skills in English language, both oral and written (fluent speaking mandatory).
Good written and oral communication skills.
Good project management skills.
Good ability to work self-organized and independently.
Good ability to accurately work on detail level.
What We Offer:
Flexible & hybrid work model.
Career development & learning opportunities
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