Senior Registration & Results Disclosure Specialist in Slough, Berkshire

Job Title: Senior Registration & Results Disclosure Specialist

Contract length:12-15 month

Location: Slough, United Kingdom

Our team at ARM are looking engage experienced candidates to strengthen our client's Patient Safety & Medical Management function. We are looking for a talented individual to fill the position of Senior Registry & Results Disclosure Lead.

What your responsibilities would be:
* Managing trial protocol registrations and coordinating results reporting on ClinicalTnals.gov & EudraCT within mandated time frames; 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.

What we would like hear about you:
* Bachelor's degree, Master's (preferred)
* Your relevant experience with clinical development, preferably trial &/or data management &/or biostatistics, or regulatory affairs (which could also have been acquired through academia)
* Experience with/or capability to identify, analyse & apply - relevant regulations & guidelines applicable to clinical research

Disclaimer

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.