John Reynolds Email and Phone Number

I lead the project team.Plan and schedule activities and deliverables Plan and manage resourcesManage clinical trials including study budget management, financial tracking and controlInteract with client and team leadership to ensure that the project proceeds on time and within budget

I lead a multidisciplinary team in the process of client engagement, planning, building, maintenance and retirement of trial interactive systems, which are responsible for randomisation and stratification of subjects as well as product inventory control functions within clinical trials. I am the client’s primary point of contact in all matters regarding the Interactive Technologies Group (ITG).I Build client relationships to develop new business opportunities.I develop and maintain the budget for the lifespan of ITG’s involvement with a trial.I actively lead coach, motivate and mentor the Project Leaders and other junior staff.I manage project risks and risk mitigation activities while maintaining compliance with company and departmental procedures.

I led a multidisciplinary team in the process of client engagement, planning, setup, maintenance and close out of all laboratory activities for assigned clinical trials for companies such as Pfizer, Novartis and Genzyme in the areas of Oncology and Diabetes.I was the client’s primary point of contact in all matters regarding the central laboratory service.I developed strong relationships with clients based on a solid understanding of their needs, with a particular focus on the Novartis key strategic partnership in my second year.I ensured project deliverables were achieved on schedule, on budget and to the highest quality standards.I advised clients on regulatory considerations including FDA and regulatory guidelines and maintained awareness of regional constraints and special considerations for the execution of clinical trial projects.In conjunction with the Laboratory Director and laboratory team leads I scoped and defined the Business Requirements Document (BRD) for each project covering analytical and technical aspects, including coordination of outsourcing or any in-house development of new testing methodologies a trial may have required.I was responsible for both budget and risk management for the lifespan of the project.

Administration of two distinct research arms (rumen research and benzo [a] pyrene degradation in soil) with responsibility for project delivery and communication with stakeholders.Design and implementation of a research strategy for the complete microbial analysis of rumen samples.Application of experimental results to the rational design of a system to mitigate the production of methane by dairy cows.Fostering close working relationships with research and funding partners in UCD and Teagasc.Planning and execution of an investigation into the capabilities of select bacterial isolates to degrade the compound benzo (a) pyrene.

I conducted coastal water sampling and laboratory analysis for the EU funded “Smart Coasts” water quality research project.

Delivered clinical trials for: Merck, Bristol Meyers Squibb and Novartis in the areas of Oncology and Diabetes.Led a multidisciplinary team and was the client’s primary point of contact in the process of client engagement, planning, setup, maintenance and close out of all laboratory activities for assigned clinical trials.Established strong relationships with clients to pre-empt problems, resolve issues and drive repeat business.Advised clients on regulatory considerations including FDA and ICH GCP guidelines. Maintained awareness of regional constraints and special considerations for the execution of clinical trial projects.Managed the generation of new assays and procedures in the labs and their translation to client studies and technology transfer to Icon’s laboratories worldwide.Analysed client protocols and requirements, planning a timeline that aligned with milestones.Exercised control over trial budgets for the lifetime of the trial.

Liaised with hospital staff and multiple testing sections to ensure prompt delivery of accurate patient test results and dissemination and explanation of any requested information including test results and testing methodologies.Supported purchase, installation and validation of new laboratory equipment.Investigated non-conformance issues and determined appropriate Corrective and Preventative Action (CAPA).