Risk Based Monitoring DMEG

Risk Based Monitoring Data Management Expert Group

The RBM data management expert group focuses on driving thought leadership discussions with respect to Risk-based Quality Management (RBQM) in clinical trials and how to drive data quality and integrity outcomes that surpass legacy ways of working, enhancing the resources available to data managers. The group meets on a monthly basis to share thought leadership and experience in implementing RBQM and different approaches to monitoring and processing clinical data. This is a constantly evolving and dynamic area of clinical trials with many organisations across the industry being at different stages of their adoption. ACDM’s RBM team are currently discussing different approaches to detecting clinical trial risk from within the data, such as using Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), Statistical Monitoring, Source Data Review (SDR) and where appropriate, Source Data Verification (SDV). The team discuss implementation approaches, impact on roles and responsibilities, impact to data management, adaptive approaches and demonstrable value.

The RBM group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite more members to our growing RBM team. We look forward to hearing from you.

If you have any interest in joining this group, please click here.

Risk Based Monitoring Expert Group members

Rich Davies (Chair)
VP, Solution Expert
CluePoints

Richard Davies joined CluePoints in September 2018 and is based in the UK. As VP, Solution Expert his role is to support organizations’ adopting CluePoints solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development. He has worked for technology vendors for overt 20 years but prior to this, he worked in data management with Fisons Pharmaceuticals and Astra. Richard graduated from DeMontfort University, Leicester, with a Bachelor Of Science degree in Computer Science.

Belinda Howe
Senior Project Manager
Monash University

Belinda is a senior project manager at Monash University, Australia where she has managed multiple research projects to successful completion, with particular expertise in managing large, complex, international RCTs. Belinda has an extensive background in critical care nursing and was an ICU research coordinator for >10 years. Belinda has a Master’s degree in Public Health. She is a peer reviewer for several scientific advisory committees and granting bodies. As a project manager of studies run through an academic rather than commercial sponsor, the responsibility of data management is encompassed into this role. Managing this effectively is a challenge and also her passion.

She joined ACDM in 2018 and was excited to join the expert group given the relevance of the topic to her own interests and work. Being part of this DMEG allows her to share knowledge and also to expand current knowledge by learning from others, with a vision to share this with the wider ACDM community.

Katie Jarvis
Director, Data Management
Worldwide Clinical Trials

Katie Jarvis (Director, Data Management) has over 20 years of Data Management experience. Upon graduating from the University of Coventry in 1997 with a Bachelor of Science Degree in Applied Biology, she started her clinical research career with the Contract Research Organization Nottingham Clinical Research Limited (NCRL). Katie has been the Data Manager for numerous paper based and EDC trials from single site trials through to large, multinational studies across all study phases. As part of the Worldwide team since 2007, Katie provides management and technical expertise to ensure the department is managed and studies executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction. Since May 2019, Katie has also been working closely with the newly formed Risk Based Quality Management department to help define processes, interfaces with other departments and tools to ensure Worldwide is GCP compliant.

Nicola Mockler
Data Management Operations Manager
Cancer Research UK

Building on her BSc and PhD in Pharmacology, Nicola moved into Clinical Data Management over 20 years ago. After working for a pharmaceutical company and CROs, she then joined Cancer Research UK to lead the team of Clinical Data Managers in the Centre for Drug Development (CDD). The CDD sponsors early phase oncology trials partnering with industry and academia. Along with her responsibilities leading the team, she has been involved in the selection and implementation of EDC systems and other clinical software. Nicola has also led many cross functional process improvement initiatives. In her role, she also liaises with other managers to maintain oversight of project status, risks and quality against project goals and key metrics.

Nicola has been a member of the ACDM for the duration of her career and was keen to join the RBM DMEG to both share her knowledge of RBM from the perspective of a small sponsor, and to learn from others working in different environments.

Lorena Rodríguez
Associate Director, Data Management
TFS Develop

I started my career as Data Manager 20 years ago, right after finalizing my Degree in Statistics. Since then, I have been always in the field of Data Management in both CRO and pharma environments. I always liked programming and software, so I initially focused my career in SAS programming and CRF/eCRF design, gradually moving to Data Management activities and coordination, systems evaluation, data management initiatives and process improvement. For many years I have also acted as Project Data Manager, overseeing clinical trials and leading cross functional teams involving Data Management, Statistics, Programming and Safety.

I am currently participating actively in the definition and update of the RBM strategy and processes within my company so being part of the Risk Based Monitoring Group Expert is a great opportunity to learn and share experiences and knowledge on the exciting and constantly evolving RBM world.

	Rich Davies (Chair) VP, Solution Expert CluePoints Click to view biography Richard Davies joined CluePoints in September 2018 and is based in the UK. As VP, Solution Expert his role is to support organizations’ adopting CluePoints solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development. He has worked for technology vendors for overt 20 years but prior to this, he worked in data management with Fisons Pharmaceuticals and Astra. Richard graduated from DeMontfort University, Leicester, with a Bachelor Of Science degree in Computer Science.
	Belinda Howe Senior Project Manager Monash University Click to view biography Belinda is a senior project manager at Monash University, Australia where she has managed multiple research projects to successful completion, with particular expertise in managing large, complex, international RCTs. Belinda has an extensive background in critical care nursing and was an ICU research coordinator for >10 years. Belinda has a Master’s degree in Public Health. She is a peer reviewer for several scientific advisory committees and granting bodies. As a project manager of studies run through an academic rather than commercial sponsor, the responsibility of data management is encompassed into this role. Managing this effectively is a challenge and also her passion. She joined ACDM in 2018 and was excited to join the expert group given the relevance of the topic to her own interests and work. Being part of this DMEG allows her to share knowledge and also to expand current knowledge by learning from others, with a vision to share this with the wider ACDM community.
	Katie Jarvis Director, Data Management Worldwide Clinical Trials Click to view biography Katie Jarvis (Director, Data Management) has over 20 years of Data Management experience. Upon graduating from the University of Coventry in 1997 with a Bachelor of Science Degree in Applied Biology, she started her clinical research career with the Contract Research Organization Nottingham Clinical Research Limited (NCRL). Katie has been the Data Manager for numerous paper based and EDC trials from single site trials through to large, multinational studies across all study phases. As part of the Worldwide team since 2007, Katie provides management and technical expertise to ensure the department is managed and studies executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction. Since May 2019, Katie has also been working closely with the newly formed Risk Based Quality Management department to help define processes, interfaces with other departments and tools to ensure Worldwide is GCP compliant.
	Nicola Mockler Data Management Operations Manager Cancer Research UK Click to view biography Building on her BSc and PhD in Pharmacology, Nicola moved into Clinical Data Management over 20 years ago. After working for a pharmaceutical company and CROs, she then joined Cancer Research UK to lead the team of Clinical Data Managers in the Centre for Drug Development (CDD). The CDD sponsors early phase oncology trials partnering with industry and academia. Along with her responsibilities leading the team, she has been involved in the selection and implementation of EDC systems and other clinical software. Nicola has also led many cross functional process improvement initiatives. In her role, she also liaises with other managers to maintain oversight of project status, risks and quality against project goals and key metrics. Nicola has been a member of the ACDM for the duration of her career and was keen to join the RBM DMEG to both share her knowledge of RBM from the perspective of a small sponsor, and to learn from others working in different environments.
	Lorena Rodríguez Associate Director, Data Management TFS Develop Click to view biography I started my career as Data Manager 20 years ago, right after finalizing my Degree in Statistics. Since then, I have been always in the field of Data Management in both CRO and pharma environments. I always liked programming and software, so I initially focused my career in SAS programming and CRF/eCRF design, gradually moving to Data Management activities and coordination, systems evaluation, data management initiatives and process improvement. For many years I have also acted as Project Data Manager, overseeing clinical trials and leading cross functional teams involving Data Management, Statistics, Programming and Safety. I am currently participating actively in the definition and update of the RBM strategy and processes within my company so being part of the Risk Based Monitoring Group Expert is a great opportunity to learn and share experiences and knowledge on the exciting and constantly evolving RBM world.