Roy Raphael Email & Phone Number

United Kingdom

Chandlers Ford, England, United Kingdom

Therapeutic Area: OncologySupport the Global Clinical Trial Manager and provide oversight of Amgen global clinical trials. Provide essential document management, tracking and collating study data and metrics using a number of clinical systems. Compile IRB/EC submission documentation. Coordinate, author and manage the preparation of clinical trial documentation and training materials (including investigator meetings, site evaluation and initiation training). Facilitate the development of Investigational Product Information Manual and study-specific Important Protocol Deviation list. Manage processes for planning, procuring and oversight of ancillary clinical supplies. Create and manage study-specific tools, including Global/country level recruitment and retention materials. Vendor management (including set up, tracking and issue resolution over the life of the study)

Perth, Australia

Acted as the primary link between clinical trial sites and sponsor working as a site monitor to ensure that clinical trials were conducted and documented as per ICH GCP guidelines, global and local regulatory requirements and Institute SOPs. Provided support to project managers, clinical and pharmacy teams as required. Assisted in compilation and review of adverse event information, provided oversight of data correction and collaborated with the data management groups reviewing clinical data/information.

Perth, Australia

Proactively managed project level operational aspects of Clinical Trial Team including management of trial timeline, budget, resources and vendors. Supported and collaborated with multiple health professionals/organisations to conduct a large double-blinded, multi-centered study. Accountable for achieving successful delivery of clinical team activities at the project level by meeting ICH GCP, regulatory and company requirements according to time, quality/scope and budget constraints. Focused on efficiencies through the introduction of process improvements and best practice techniques.

Southampton, United Kingdom

Clinical Trial Manager and Clinical Trial Associate November 2015-January 2018Southampton Clinical Trials Unit, Southampton University/University Hospital SouthamptonCTM responsibilities included: trial set-up in collaboration with Chief and Co-investigators, Clinicians, Research Nurses, Statisticians, data managers and other relevant personnel; identifying sponsor specific processes and requirements; writing and designing all trial documents including the protocol; development and testing of bespoke trial database; identifying when protocol amendments were necessary and taking appropriate action; ensuring regulatory requirements were fulfilled and that all approvals and authorisations were secured; trial site set up and activation; explaining and promoting trials (including newsletter production, website updates) to ensure wide participation and good accrual of patients; overseeing risk management and mitigation; visiting clinical centres and monitoring trial conduct and drug accountability as appropriate to ensure protocol compliance, good patient management and ensuring GCP guidelines were adhered to; ensuring screening data was reviewed regularly; writing and submitting trial progress reports as and when required, including reports for trial funders and Research Ethics Committees. CTA responsibilities included: coordinating day-to-day activities and overall operational management of the Stratified Medicine Program for lung cancer at UHS and across seven other feeder hospitals; providing effective and efficient operational and administrative support to program staff; ensuring tight protocol driven procedural timelines were met; coordinating feedback of results to clinical teams for potential entry of patients to the National Lung Matrix Trial; managing the clinical trial databases, transcribing and exporting data from medical records & IT systems to CRFs; creating monthly sponsor KPI reports.

London, United Kingdom

Worked closely with Team Leader (TL) in all organisational, operational and financial aspects of the Food Service department. Regularly carried out TL’s duties and responsibilities (full profit and loss accountability) including financial and managerial reports for Store and Regional leadership. Performed product purchasing function, inventory control of department sales floor and back stock, and analysis of sales and labor reports. Instrumental in helping Team to achieve and surpass departmental profit and store profit contribution goals and to become top performing department Team in the UK region delivering a like-for-like sales increase of 13.6% for 2011 fiscal year. Helped manage and develop Teams of 15 and 25 people to achieve regional KPIs. Utilised coaching and leadership techniques to inspire and enable all direct reports to achieve their full potential. Ensured that the high-level customer service standards set by the company were met. Enforced operational standards and stock loss controls to minimise shrink, waste and labour costs that resulted in significant savings. Developed and maintained a culture of high safety and security standards and hygienic practices in compliance with all applicable national and regional Health and Safety policies and standards. As Green Mission President implemented sustainable store-wide recycling programme and energy and resource reduction policies. Regularly worked as Store Duty Manager driving, measuring and re-inforcing standards. Earned Level 3 Award in Supervising Food Safety in Catering. Completed company’s Supervisor/Leadership Training Series.

Bachelor Of Arts (Ba), Philosophy & Political Science

Master Of Arts (Ma), Environmental Leadership/Systems Science