ACDM Board

I have been in the pharmaceutical industry for over 23 years, working in both CRO and Pharma, most of this time in biometrics (clinical data management, stats programming). I’ve now been on the board of the ACDM for many years, and it has been very challenging but rewarding to be able to bring people together, to learn, and share knowledge. My remit has been primarily to communicate with the membership to highlight activities, try to ensure that the website is constantly changing, introduce revenue streams and new special interest groups, and ensure that the ACDM stays in the number one spot in internet search engines. This ever-changing industry has thrown so may challenges our way, it has been hard work keeping the association going despite companies cutting back on spending. I don’t easily give up, and despite moving into a completely different area of work as a Global Metrics Strategy Leader, it has not deterred me from spending some of my own time working with fellow dedicated board members to keep the momentum of the ACDM moving forward.

Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in Management and IT Consulting, in the healthcare and life science industries at major service providers for Clinical Research and Data Management.

Now Bertrand runs PharMarketing, an operational consulting company based in France and acting in Europe and US, delivering services regarding Data Privacy, GxP, quality compliance, legal representation and IT Best Practices.

He is speaking regularly at industry conferences in Europe and US, and sits at the Board of Data Management Biomedical and Association for Medical Professionals AMMIS.

Jo started her career as a Data Manager in Searle back in the 1990’s, where she developed to a high level global data manager role, with particular expertise in new technologies and process improvement. This is also where her career in the ACDM began as part of the website sub-committee and gaining the MSC in Clinical Data Management that the ACDM set up in conjunction with Kingston University. After several mergers and acquisitions Jo left the pharmaceutical company side of the industry and started working with an Entrepreneur in a start-up CRO. Together they grew the company, developing a reputation for quality and expertise in Biometrics and Jo became the Managing Director of MDSL International after 5 years broadening her data management experience into strategic management. In 2013 CROS NT acquired MDSL International and Jo became the UK Country Manager, working on a number of special projects while maintaining her strategic management responsibilities, including Integration, Quality Management Systems, Continuous Improvement, Functional Service Provision, HR, Business Development. In 2019 Jo moved to her current position at Phastar as Director, Clinical Data Management for the global CRO. Jo joined the ACDM conference committee in 2010, and acted as chair from 2014 to 2019 and also joined the ACDM board in 2014 as Treasurer.

Ioulietta joined TFS in 2021 and heads up the global division of Biometrics which covers Data Management, Biostatistics and Risk Based Monitoring as Executive Director, Global Head of Biometrics. Ioulietta is a statistician by background and has over the years worked with all different kinds of data. She has a long career working across a huge range of data systems and data warehouses, giving her a unique way of evaluating and selecting new technology systems benefits and risks.

Over the past 20 years, Ioulietta has worked across a range of industries, managing statistical, data management and software developer teams during that time. Interesting projects she has been involved to date included leading the integration of banking customer platforms during the financial recession, developing a diagnostic test determining substance abuse for the London Olympics in 2012, as well as working on umpteen trials on a range of indications – from ultra-rare diseases to large registry studies of more than 5000 patients.

Her career in the pharmaceutical industry started in 2001, as a Graduate Statistician enrolled on the first ever intake of Graduate trainees at PPD Development. Over time she worked in several small and large CROs, on a wide range of clinical trials with a particular interest in rare diseases and oncology studies.

Ioulietta holds a PhD and Masters in Medical Statistics from the University of Southampton.

Her research areas of interests are handling and managing missing data in clinical trials, decentralised trial technologies and developing successful vendor partnerships with specialist vendors to bring bespoke solutions to clinical trial implementation.

Robert King has over 29+ years of industry experience and for the last 17 years he’s had global leadership roles in Data Management/Statistics and Clinical Development support functions. Where he’s been key a driver in developing and implementing corporate strategic direction across clinical development and eClinical technologies as well as gathering significant experience in the FSP marketplace. He is presently an Executive Director at PPD accountable for the strategies and provision of client-specific customised solutions supporting clinical development. The first 10 years of Robert’s career were at Roche, Scherer DDS and Pfizer doing various roles with increasing responsibilities within the Data Management and Statistical Programming functions. Before joining Eisai in 2002 as the EMEA Head of Biostatistics and Data Management before becoming the Global Head of Data Management after 2 years. After 7 years at Eisai Robert moved to ICON where he managed ICON’s global internal consultancy group consulting on topics as diverse as risk-based monitoring, eTMF/CTMS technologies and Corporate SOP oversight, before joining PPD in 2012. Robert first started supporting the ACDM back-in 1993 on the Technical and Conference sub-committee, which included helping organise the ACDM’s first ever conference and he also joined the ACDM board in 2000. After 11 years of supporting the ACDM in 2004 he decided it was time to “retire” from the ACDM to spend a little more time with his young twins.

Background and experience?

I started more than 30 years ago as a statistical programmer and worked myself into data management. I worked at a CRO, then I took the role as a managing director, first in Sweden and then in the USA. Close to 19 years ago I co-founded a CRO, we developed the Viedoc eClinical System. As the company expanded we separated the different parts into a CRO and Viedoc Technologies, we later sold the CRO and now focusing on the global expansion of Viedoc.

Before Viedoc I worked for the global first company in ePRO in early 90’s, the first version weighed 2 kg and had four buttons, the second version only weighed 1 kg! Praised by the users for its user friendliness and it was so easy to carry along. Later I started working at a CRO with paper CRFs and manged quite a few large studies, I was lucky to work pretty early with eCRFs, in the mid 90’s – interesting how far we’ve come!

I have focused mainly on the business development side of things but have always promoted data management and worked towards data managers. I am a teacher at the university in Uppsala in the Master Course in pharmaceutical development, specifically in Data Management and in non-interventional studies. The past year and next year I will be teaching at the university of Montpellier in specific courses in data management.

What do you hope to bring to the ACDM board?

I have enjoyed being a member in the ACDM Digital Group. I would like to continue to work for ACDM in the Board, not only to internationalise the association, but maybe also bring in the perspective of an e-clinical software developer.

Do you have any ideas you would like ACDM to take forward?

Internationalisation! Make ACDM the natural choice for all data managers. There are far too many data managers out there who aren’t members!

Ramlal Waghray has over 35+ years of experience in the industry out of which he has spent his last 15+ years working for large majors like Oracle, Arisglobal building and delivering innovative solutions for the Life sciences Industry. He has played diverse roles in his career – Consulting, General Management, Business Head managing a P & L and leading Product Engineering & Delivery units. 

He is Currently CEO, Predlytics – a Data Science company offering solutions across diverse industry verticals. He is also actively engaged in offering Strategic Consulting services in the Life sciences domain.

He is an angel investor and a mentor for startups and also a visiting professor at a leading B School teaching Data Science and Machine Learning. 

Nina Reyes (Manager, Clinical Data Management) is a certified nurse and graduated from the University of Bonn-Rhein-Sieg with a Bachelor of Science in Computer Science and Biomedical Informatics. For the last 16 years she has continuously worked in the Clinical Data Management area of various CROs with adding some experiences and skills to her portfolio with working as a Manager in the Start Up Operations and Country Management for Germany, Switzerland and Austria within one of the top 5 CROs.

Nina has always been interested in innovation and a smooth and swift implementation of it into the day-to-day work of Data Management. She is thrilled about the opportunity to be part of the ACDM eDigital DMEG and hopes to get a lot of new insights and to bring, together with the other members of this strong group, eDigital a step forward.

I am the Commercial Business Development Manager at a teaching hospital in Southampton. I have worked in clinical research for many years in many NHS Trusts & UK Universities. Now I lead on developing an extensive portfolio of commercial studies conducted at the Trust. My role is to liaise with commercial sponsors, CROs, and MedTech companies and provide a concierge service for SMEs to access patients, data and support departments required for their trial and to bring their product to the market, which sets us apart from other organisations.

I have a post-graduate certificate in Business Administration from The University of the West of England (UWE).

I joined ACDM in 2020 and am now very excited to chair the CTU data management expert group.

Eva has more than 10 years experiences within Clinical Data Management. She is currently leading the global Data Management Department (including EDC development) at the midsize CRO Ergomed. She has oversight over 35 employees on 3 continents.
Before Eva was at a software company doing requirements engineering for an EDC and trial management software. She also has experiences within academics, economics, and taxes.