Clinical Trials Disclosure Associate
The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.
Person will be responsible for coordinating the posting of registration and disclosures on clinical trials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinicaltrials.gov and EudraCT disclosure).
Must be database proficient with registrations and disclosures. Has the ability to work cross-functionally and meet required deadlines. Ensures trial disclosure is in compliance with applicable regulations globally. Develops and maintains strong internal relationships across all levels of the clinical organization.
Escalates issues to management in an expedient manner. Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures.
On occasion, responsibilities may be extended to:
- reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion
Coordinates all Eisai clinical disclosure activities, acting as primary intermediary between the disclosure vendor and Eisai contacts 30
Works with Eisai contacts to identify and resolve compliance gaps 30
Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel 20
Maintains Eisai disclosure trackers and produces metrics reports for management 10
Maintains Eisai product information for use in disclosure activities 10
Bachelor’s degree required
At least 3 years working in the pharmaceutical industry in an R&D environment.
Solid knowledge of clinical trial transparency principles, preferably on an international level
Strong attention to detail and the ability to work as a part of a team across multiple departments
Strong communication and influencing skills
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