Product Manager for uMotif’s innovative, patient-centric data platform, consisting of patient-facing iOS and Android Apps, associated web portals and Content Management System, used for ePRO and patient diary collection in late phase and Real World Evidence trials.Product Manager for uMotif’s new platform, enhancing uMotif’s offering to support interventional, Phase I to III clinical trials. The platform was completed and deployed on time for use in uMotif’s first early-stage trial for a top 10 pharma company.Successful delivery of a portable SDK version of uMotif’s primary UI component for a top 10 pharma client, to be embedded into their inhouse software applications.Managing and mentoring uMotif Product Owners.SME / internal consultant for clinical trial conduct and operations.Agile development using Scrum and Kanban frameworks.

Product Manager for Cmed’s new clinical data suite, Encapsia, comprising a cloud-based server, eSource App for iPad and a constellation of web apps covering EDC, CDMS, risk-based monitoring, trial management, issue tracking, archive, automated third party data loads and collaboration tools. Technologies include cloud-hosted web / database server, native iOS development, HTML5, Oauth2, JavaScript and web development using Backbone, Angular, React, etc.Starting from a blank page to propose new software solutions: analysing market needs, leading global requirements workshops at clinical sites, collating business intelligence, creating a development strategy, creating vision / requirements / design documentation.Product Owner and technical authority for multiple outsourced and internal development teams.Product and Project Manager for the integration of Clinical Ink’s SureSource eSource product with Cmed’s Timaeus EDC/CDMS. The pilot trial was the first integrated eSource trial to be submitted to the FDA and the project won the 2012 SCDM Data-Driven Innovation Award.

Analysing protocols and leading customer-facing meetings to create user requirements for IVR, IWR and ePRO systems and system integration functionality.Co-ordinating global teams of in-house / outsourced programmers and validators during the development phase, from business development handover to Go Live.Liaising with other ICON groups and external vendors regarding system definition, integration and process improvement issues for RTSM, EDC, ePRO, CTMS, Labs, etc.Three month secondment to Texas to provide subject matter expertise on process improvement.Consulting on operational, technical and process topics concerning software definition and delivery.

Senior position within the Product Strategy group, architecting complete business solutions to operational and product level problems: analysis, development, deployment and training.Initiative owner for Medidata’s new product (now Medidata Balance): developing the original concept of a self-service randomization system; developing a business plan and technology road map; board level presentations; budgeting; evangelising the product; leading a cross-functional team.Gathering market intelligence relating to specific business areas to underpin corporate strategic initiatives and support decisions to buy / build / partner in new technology areas.Product design, developing high level design using prototyping and user stories.Subject matter expert on randomization, drug management, unblinding and the CDASH initiative.

Travelling to Client sites in UK and Europe, leading specification / requirements meetings and consulting on the design of EDC systems for clinical trials.Analysing protocols and requirements to produce design specifications for EDC systems.Liaising with offshore development teams and local resources through build, QC and test phases.Consulting on EDC system design, databases and 3rd party integrations (e.g. IVRS, diary, coding).Contributing to functional development of the Rave platform and best practice processes for its use.

Project managing the implementation of Aris Global’s pharmacovigilance products to corporate and governmental Clients in Europe: implementing project plans, allocating and co-ordinating resources.Leading Aris Global’s satellite office in London.Developing installation & production qualifications, installation workbook and validation plans and performing product installations at Client sites.Providing consultancy services to Aris Global’s current and future Clients.

Managing the CTC’s IVR consulting unit: liaising with Clients; developing requirements; designing, specifying, coding, testing, deploying and monitoring software for these trials.Gathering requirements and designing a generic Drug Management System: web-based, multi-user platform for stock management, shipment tracking, drug dispensing, accountability and reporting.Analysing protocols and CRFs to develop user requirements for randomization, drug management and unblinding systems and participating in ongoing development work as a subject area specialist.Maintaining and monitoring ongoing trials, liaising with internal and external sponsors and representatives, performing database analysis, resolving queries and producing reports.Developing and implementing a suite of management reports across all trials in the CTC's portfolio.Data management of all randomization and unblinding codes and lists.Writing SOPs for randomization and unblinding process.Lecturing in Advanced Data Management for Clinical Trials.

Leading programming teams in developing software for some 30 trials over 4.5 years, for most of the major pharmaceutical companies.Responsible for full SDLC, producing IVR applications for randomization, drug management and unblinding.Seconded to the US for three months as technical lead in the fledgling US office, providing sole technical support for 5 Clinical Project Managers and interviewing candidates to fill TPM roles.Performing as a supervisor in the British Computer Society's Professional Development Scheme, mentoring and supervising staff development.