The Board of Directors and Leadership Group bring a wealth of experience to the ACDM
The Board of Directors currently comprises of volunteers, who all work in the industry and are current members of the ACDM. The Board is elected by the members of the Association, inline with the associations memorandum & articles. Their role is to manage the association, develop the association to achieve the vision, goals and aims and to provide members with the services and benefits they require from their association.
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.
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!
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.
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.
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.
My connection to the world of clinical data management began when I was at university. My course was Computer Science at De Montfort University in Leicester, and the course involved a placement year in industry during the third year. I secured a placement working at Fisons Pharmaceuticals in Loughborough, working in the clinical data management department helping to implement a new system that they had recently acquired, called Clintrial. Having finished my degree I went back to work at Fisons before joining the company (BBN) who had created the Clintrial CDMS system. From there on I’ve worked in various suppliers of eClinical solutions. I’ve spent a lot of time working with EDC systems (Phase Forward/Oracle) and watching the industry move from paper to electronic data capture. Along the way though I’ve had the chance to work with all kinds of supporting systems, such as Pharmacovigilance, PV Signal Detection, Phase I Clinic Automation, Late Phase EDC, Statistical Computing Environments, Clinical Repositories/Warehouses, ePRO, CTMS, Regulatory Management and now Risk-based Quality Management at CluePoints.
I am an experienced data manager for various therapeutic areas with additional certifications in business data science, digital transformation and strategic management. My experience ranges from clinical data management to system lifecycle management and supplier management with a focus on clinical trials. In addition, I have several years of experience with digital and agile transformations, including organizational development, as a leader in various positions. I spent two years building and leading the digital innovation, systems and capabilities leadership team in medicine and in this role also drove the strategy for the One Medicine Platform. I am super passionate about data and technology, disruptive change and simplifying complexity.
Anita Kratchmarov
Board Member | Bayer Pharmaceuticals
I have close to 25 years of DM experience in various pharma companies and therapeutic areas starting in 1999 with Merck, and followed by Schering Plough, NPS, Eisai, Novartis, and Bayer Pharmaceuticals at present. My educational background is MSc in Biochemistry and Microbiology, and a BSc in Nursing. My DM expertise spans beyond knowledge of FDA, ICH, GCP/GCDMP principles, to industry-specific globally regulated clinical data requirements and trends, i.e. EHR@EDC, DCT, etc. I strive to apply this knowledge in a globally run, digital, data-driven environment and support the delivery of high-quality data outputs crucial for regulatory submissions and scientific publications. My passion is trouble shooting, coaching, and mentoring across a 360° spectrum, including DM, global Clinical Operations staff, Clinical Development peers, interns, CRO partners, and vendors and I bring extensive Clinical R&D experience, predominantly in therapeutic areas such as Oncology, Infectious Diseases, Cardiovascular, Gastrointestinal, and Cell & Gene Therapy.
As an experienced data manager leader I have worked across therapeutic area disciplines within both the pharmaceutical and CRO industries. I have over 14 years experience in Clinical Data Management and started my career in the late phase Data Management department at PAREXEL. I progressed into a Data Management operational leadership position where I had overall accountability, as an account lead, for the execution of the Data Management strategy on numerous complex Oncology studies.
I joined the Oncology team within the Data Monitoring and Management department at Pfizer in 2018 and am currently a Director, Senior Asset Lead supporting the development of a number of key, pivotal compounds. I am also business lead for Pfizer’s development and implementation of the Smart Data Query (SDQ) tool, an industry first leveraging AI/ML to hyper-accelerate complex data review and reconciliation activities. In addition I also supports a number of other innovation projects within Pfizer in the fields of AI/ML and RBDM.
I hold a Bachelor of Science degree in Biology from Sheffield Hallam University, UK.
Amelie is currently Associate Director CDM platform at BioNTech. Amelie is a Molecular biologist by training. Amelie’s career has involved leading Data Management and biometrics team across the world in CRO (IQVIA, PAREXEL, Bioskin, Labcorp, Cytel) and in Pharma ( Bayer, BioNTech). Amelie is passionate about knowledge-sharing and making her team grow. Amelie says that “Data Management is a job that keeps evolving and I am happy to be part of ACDM board to shape and lead the future of clinical data management”
