Senior Registry & Results Disclosure Lead

We are recruiting for a Patient Safety & Medical Management function we are looking for a talented individual to fill the position of Senior Registry & Results Disclosure Lead. This role can be remote of based onsite.

As a Senior Registry & Results Disclosure Lead you will have the following responsibilities:

• Managing trial protocol registrations and coordinating results reporting on ClinicalTnals.gov & EudraCT within mandated timeframes; completing initial data entry based on protocol working in close collaboration with study teams; managing day-to-day collaboration with vendor(s) as required

• Coordinating review and approval of study Disclosure Plan & Results Master Document by relevant stakeholders

• Extracting information from clinical trial management system databases at regular intervals and updating study records on registries as required, updating study records with links to product labels & citations of publications

• Serving as Initial Point of Contact with the National Library of Medicine QA Group to resolve questions prior to public release of data on ClinicalTnals.gov

• Updating project tracking systems, maintaining complete, accurate & consistent records reflecting entry of data onto registries; archiving related documentation

• Developing and maintaining efficient working relationships with contributing departments (e.g., Clinical Project Management, Statistics, Medical Writing, Regulatory Affairs, Safety)

• Supporting local teams/vendors responsible for data entry into local registries to ensure consistency of trial information disclosed across national registries

• Preparing presentations / providing training to internal stakeholders on clinical trial disclosure-related guidelines & processes

• Providing input into transparency-related projects/initiatives.

Must Have

Clinical trial disclosure experience