With over 11 years of expertise in the eTMF/TMF field, Becky has collaborated in roles within both sponsor and eTMF vendor organisations. As the CDM System Design & Interfaces Team Lead at Novartis, she
focuses on driving strategic initiatives and planning, along with overseeing the operational aspects of document management systems. Specialising in eTMF system delivery, document migrations, change con
trols, and validation practices, Becky also brings valuable experience in TMF Management and Project Management. Her diverse background underscores a strong knowledge foundation and a dedication to
achieving successful outcomes within the TMF landscape.
Avani Amin
Avani Amin has 18 years’ experience in TMF Management and oversight, having worked across multiple FSP TMF providers. Initially key member of the Project Management team supporting clients across the top 30 global pharmaceutical firms, Avani now co-leads the eClinical Solutions Management unit and the Study Owner unit at Trial Interactive, directing TMF Oversight across 200 keystone clients. In this capacity, she regularly oversees system implementation, provides best practice guidance, and ensures ongoing customer success for Trial Interactive premier clients.
Avani leverages her 18 years in the industry to provide accurate, clear TMF consulting for a range of customers; assisting clients with industry best practices, optimization of eTMF and CTMS systems, business process development, and SOP/TMF plan creation.
As the industry evolves with the onset of new technology, she is well placed to communicate accurately Regulatory expectations and TMF requirements to ensure clinical compliance across the CDGM space.
Gillian Gittens
Gillian Gittens is a TMF industry veteran with over 25 years’ experience, has a wealth of insight and expertise in managing TMF services and delivering ongoing customer success across all aspects of TMF operations. A key member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative, Gill has key expertise and insight in industry best practice, regulatory guidance and the future of TMF management.
Henry Raley
Henry has been supporting clinical activity across the pharmacovigilance, CRO, and now TMF FSP space for 12 years; and has supported 50+ eTMF implementations and 30 FSP model activations in the last 18 months. Working across multiple support models, he remains a market leading expert in adaptable compliant workflows for full TMF compliance.
He works directly with sponsors, providing full TMF management, alongside CROs as a collaborative partner, and advises on appropriate technology platforms and configurations based on client need. He also sits at the forefront of the TransPerfect AI rollout, helping with AI for TMF Management, eCTD Submissions, and Medical writing.
Graham Downing
Graham Downing is Vice President of Biometrics at MAC Clinical Research. Graham brings over 35 years of experience that spans Pharmaceutical and Biotechnology companies as well as both large and mid-sized CROS. Over his career, Graham has led teams engaged in Statistics, Data Management, Programming, Database Development, EDC, Systems Management, Medical Writing, Transparency & Disclosure, Clinical Development Technology and Clinical Innovation. During his 12-year tenure at one of the major global CROs, he held positions of increasing responsibility leading to being Vice President Global Statistics and Programming. Having begun his career in the UK as a Statistician, Graham spent approximately 9 years living and working in the USA, followed by a return to the UK and then for over ten years before joining MAC was based in Germany. Graham is a data-driven clinical development professional with extensive experience leading data operations, analysis and reporting, and championing technologies streamlining execution and connecting the end-to-end process; at MAC he leads an experienced, talented team supporting both full-service studies and standalone Biometrics offerings.
