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Senior Registry and Results Disclosure Lead
4 months ago
**SENIOR REGISTRY AND RESULTS DISCLOSURE LEAD**
15-month+ contract
Fully remote
Inside IR35
**Your new company**This is a global pharmaceutical company dedicated to developing innovative treatments for patients living with neurology, immunology, and rare diseases. Their commitment to research and development is at the forefront of their mission, as they strive to bringlife-changing therapies to those who need them most.
**Your new contract role**:
- Managing trial protocol registrations and coordinating results reporting on ClinicalTrials.gov & EudraCT within mandated timeframes; completing initial data entry based on protocol working in close collaboration with study teams; managing day-to-day collaborationwith 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 ClinicalTrials.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.
**What you'll need to succeed**
- Bachelor's degree, Master's preferred
- Experience in the transparency and disclosure space
- Experience using PharmaCM or TrialScope
- Redaction and data-sharing experience is a plus
- German is a plus
**What you'll get in return**
Flexible working options available.
**What you need to do now**
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
