Doug Webb

Experience

• 

  MRC Epidemiology Unit

  Sept 2009 - Aug 2010

  Year in Industry Student

  I provided administrative and practical support to research studies, developing valuable clerical skills, practical research skills, and communication skills.

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  MRC Epidemiology Unit

  Nov 2011 - Dec 2014

  Responsibilities included working with elderly study participants to obtain measures of anthropometry, lung function, physical performance, grip strength, body composition and bone density. Responsible for providing administrative support in the study office. My duties included sending mail outs, scheduling study appointments, resolving participant queries and data entry.

  • Research Assistant

    Jun 2012 - Dec 2014

  • Clinical Research Project Support

    Nov 2011 - Jun 2012
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  University of Plymouth

  Jan 2015 - Jun 2018

  Assistant Trial Manager

  • Supported the delivery and continuous development of a customer focused and efficient trial management service for chief investigators, sponsors and site teams. Duties included: Protocol development, study document development, preparing ethical and regulatory submissions, maintaining study approvals, preparing and maintaining Trial Master Files, site training and initiation, routine and for-cause study monitoring, planning and maintaining trial supplies, preparing progress reports, site close-out. Show less

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  University of Bristol

  Jun 2018 - Jun 2022

  Trial Manager

  Responsible for delivery of randomised controlled trials conducted in the UK and Australia, taking an active role on a trial to ensure key project milestones are achieved to time and budget. Duties include:• Leading on the development of essential study documents for ethical and regulatory submissions using IRAS. • Ordering and overseeing the timely supply of kits to trial pharmacies internationally. • Procuring drug supply and pharmacy services.• Ensuring trials comply with appropriate governance frameworks and regulations, such as ICH-GCP. • Amending the study if required to improve study progress, maintaining study ethical and regulatory approvals. • Managing risks to a study; supporting the development and implementation of study monitoring plans. • Developing effective systems for capturing, storing, reporting, and monitoring data using decentralised methods, such as eCRF development, and systems for raising and resolving data queries. • Designing bespoke systems to support decentralised study delivery.• Monitoring patient recruitment and retention; reviewing data collected for quality and completeness.• Monitoring study budgets, approving invoices, supporting routine financial reporting. • Conducting site feasibility assessments and selection. • Training staff on study processes and leading site kick-off meetings. • Writing trial progress reports for oversight groups and funders. • Managing recruitment of new trial staff. • Supervising and line-managing trial staff. • Building strong working relationships with key trial stakeholders to ensure delivery of trial milestones. • Supporting the execution of study contracts, such as collaboration agreements and site agreements. Show less

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  IQVIA

  Jun 2022 - now

  System Design Project Manager (IRT)

  Responsible for the successful design and delivery of Interactive Response Technology (IRT) systems. Duties include:-Main point of contact for client and internal cross-functional teams on individual studies-Authoring, reviewing and finalizing study User Requirements Documentation (URS) for the IRT system. -Managing technical aspects of IRT design -Analysing the study protocol, identify study needs related to user, patient, and drug supply management. -Identifying and mitigating project risks-Reviewing final system requirements against initial proposal, managing needed budget changes-Writing test scenarios, working with cross-functional teams to ensure studies are delivered to high quality standards, and in accordance with Good Clinical Practice and Standard Operating Procedures. -Writing User Acceptance Testing (UAT) scenarios, reviewing and approving them with client -Manage UAT set-up activities, and support client during their UAT-Lead on investigations and issue resolution-Forecasting project hours, and billing Show less