Gaven Royce Micr

Pm Cra Regional Expert Scra Msd Uk & Ire Ucra Cpoc @MSD

Project Management role: Study Management for NSCLC & HIV studiesRegional Expert CRA Role:Working closely with CRN networks and contacts to better implement and facilitate study start upValidation Team: Active in suggesting and expanding research locations in the West of England and Wessex regions of UK. Across all disease areas and facilitating working with newer sites across the CRN network. Current workload involves 5 Phase active trials with 8 UK sites: HIV, Cardiovascular, Crohn’s disease & Essential Thrombocytothaenia therapy areas. MHRA Inspection Team June 2016, June 2020 & November 2023Lead / Co-ordinating CRASubject Matter Expert - uCRA POCUK & IRE CPOC role for uCRA outsourced team management, metrics, KPI, conflict negotiation, provisioning and POC for issue resolutionPivotal Victoria & VICTOR Cardiology trials - turned around non- recruiting sites into over-recruiting sites. Led validation effort in IRE to open rescue sites in rapid timeframe. Directly assisting CRM in this endeavour. Successful ID and recruitment of 5 IRE sites with full setup completion.Facilitated over-recruitment for 2 HIV Centres during COVID-19 lockdown. 1st subject Randomised in UK & IRE for 3 studies.Completed 4 HIV studies from start to close out, managed multiple trials in one location across 2 facilitiesActive management of all aspects of study, site and protocol management from startup to close.Continual assistance for sponsor, HQ & external personnel.Constantly achieves all DBL/IA timelines, objectives, study milestones, safety timelines, endpoint evaluation and PI e-signature.Identified potential cost saving measure in reducing waste, reducing paperwork and resulting queries to rectify with an external lab vendor process improvement.