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.

Raven Brothers
Associate Director of Clinical Data Abstraction
Natera

Raven Brothers is an expertly skilled clinical research professional with extensive clinical data management and abstraction experience, including managing clinical data collection and developing secondary use real-world deidentified datasets. She is an organized, strategic thinking, seasoned leader capable of managing small and large teams while solving complex problems to achieve business goals. She has a firm grasp of clinical trial operations, GCP, GCDM, DMBOK, DAMABOK, and CFR Title 21 Parts 11, 50, 56, 312, and 812.

Raven grew up in Washington, DC, and graduated from one of the city’s major public high schools. She furthered her education by obtaining a bachelor’s degree in Biology from Elizabeth City State University (2008) and a graduate degree in Clinical Research from The George Washington University (2017). During Raven’s undergraduate studies, she obtained certification as a nursing assistant and during her CNA studies she volunteered at a nursing home. Raven has led an influential career performing clinical data management, including directing peak-performing teams to create and process high-quality clinical unstructured and structured data sets and ensuring staff appropriately apply HIPAA and organizational-wide data handling and de-identification procedures to ensure patient health information protection and privacy.

Raven started her career in less than two weeks upon graduating from her undergrad studies. She joined Westat in 2008 and worked there for close to four years before advancing her career by joining Harris Corporation as a Clinical Data Manager 1 supporting the department of defense’s Vision Center of Excellence Defense and Veterans Eye Injury and Vision Registry (DVEIVR) program. In 2017 Raven left Harris Corporation as a Clinical Staff Supervisor to lead the American Society of Clinical Oncology’s (ASCO) CancerLinQ (CLQ) clinical data management operations. Raven quickly advanced to Project Manager in 2017 and then Associate Director of Commercial Operations in 2019, overseeing all of CLQ’ commercial data activity, including quality assurance and control procedures and the creation of small to large real-world de-identified research datasets for pharma and academic institutions. Additionally, Raven managed all CLQ curation activity performed externally by Tempus and Concert.AI. In October of 2020, Raven joined Natera as Associate Director of Clinical Data Abstraction, where she is overseeing all data abstraction and management activity for the Oncology business unit.

Raven is a member of six professional organizations, ACDM, ACRP, DAMA, PMI, SCDM, and SOCRA, and holds three professional certifications, ACRP-CP, CCRP, and PMP.

Throughout the past ten years, Raven has participated in various non-profit organizations and initiatives and enjoys volunteering to support veterans, the elderly, and the homeless. Raven enjoys spending time with her family and fishing. Raven holds herself to high professional ethical standards and approaches each task with three principles she created to define her brand- “I will remain teachable, I will always be approachable and available, and finally, my success is measured by the success of my team and staff.”

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.

Magdalena Kozlowska
Director, Clinical Data Management Group
GSK

Magdalena Kozlowska is working with GSK as a Director within Clinical Data Management group, division of DS&M. She is a leader with demonstrated history of working in the pharmaceuticals and CRO industry, with deep DM knowledge combined with business oriented acumen. Experienced with team building, recruitment, new DM biz development. Skilled in set up and maintaining clinical studies across all phases within many TAs, mostly oncology. Creative, passionate and dedicated expert with strong industry know how. Research professional with Masters degree focused in Pharmacy from Medical University of Warsaw and PhD student within eHealth field.

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.

Rachel Oakley
Senior Director
Cmed

Rachel has 19 years’ experience in the clinical research industry, starting out in clinical operations, moving into Functional Service Provision (FSP), and since 2015 has been involved in the implementation, growth and oversight of Risk-Based Monitoring (RBM), including centralised monitoring.

Rachel’s most recent focus was consulting with clients that wanted to either implement an RBM methodology, wanted to improve their existing RBM methodology, or wanted to employ technology to support their RBM methodology (mainly risk assessment and management tools, and KRI dashboards). Her current role is Senior Director of Centralised Monitoring at Cmed.

Nina Reyes
Manager Clinical Data Management
IQVIA

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 RBM DMEG and hopes to get a lot of new insights and to bring, together with the other members of this strong group, RBM a step forward.

Lorena Rodríguez
Principal Clinical Data Manager
Cmed

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.

Helen Smith
Senior Data Coordinator
PHASTAR

I have worked in Clinical Data Management for over 20 years, based in the UK. I started my working career as a nurse and moved into Data Management following my degree in Zoology and Psychology at Reading University. I have worked for CROs during this time and have gained a wide variety of operational study experience.

I joined PHASTAR earlier this year and am relatively new to Risk-based Quality Management. I am really pleased to have the opportunity to join the RBM DMEG. I am looking to represent the company to explore how we can further our proactive and targeted approach to data cleaning and delivering high quality data. It is a great opportunity share knowledge and experience within the industry.

Achilleas Zaras
Sales Engineer
eClinical Solutions

Achilleas has 14+ years of experience in the software industry which involves providing Clinical Data Hub solutions for Pharmaceutical companies and biotech’s, managing software development teams, hands-on coding in Microsoft .Net platform as well as Business Intelligence Suites like QlikSense. Having enjoyed a progressive career in diverse roles including responsibilities of a Solutions Consultant, Team Manager, Software Engineer and Business Intelligence Analyst in various sectors like Banking, Retail and now the Pharmaceutical industry.

	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.
	Raven Brothers Associate Director of Clinical Data Abstraction Natera Click to view biography Raven Brothers is an expertly skilled clinical research professional with extensive clinical data management and abstraction experience, including managing clinical data collection and developing secondary use real-world deidentified datasets. She is an organized, strategic thinking, seasoned leader capable of managing small and large teams while solving complex problems to achieve business goals. She has a firm grasp of clinical trial operations, GCP, GCDM, DMBOK, DAMABOK, and CFR Title 21 Parts 11, 50, 56, 312, and 812. Raven grew up in Washington, DC, and graduated from one of the city’s major public high schools. She furthered her education by obtaining a bachelor’s degree in Biology from Elizabeth City State University (2008) and a graduate degree in Clinical Research from The George Washington University (2017). During Raven’s undergraduate studies, she obtained certification as a nursing assistant and during her CNA studies she volunteered at a nursing home. Raven has led an influential career performing clinical data management, including directing peak-performing teams to create and process high-quality clinical unstructured and structured data sets and ensuring staff appropriately apply HIPAA and organizational-wide data handling and de-identification procedures to ensure patient health information protection and privacy. Raven started her career in less than two weeks upon graduating from her undergrad studies. She joined Westat in 2008 and worked there for close to four years before advancing her career by joining Harris Corporation as a Clinical Data Manager 1 supporting the department of defense’s Vision Center of Excellence Defense and Veterans Eye Injury and Vision Registry (DVEIVR) program. In 2017 Raven left Harris Corporation as a Clinical Staff Supervisor to lead the American Society of Clinical Oncology’s (ASCO) CancerLinQ (CLQ) clinical data management operations. Raven quickly advanced to Project Manager in 2017 and then Associate Director of Commercial Operations in 2019, overseeing all of CLQ’ commercial data activity, including quality assurance and control procedures and the creation of small to large real-world de-identified research datasets for pharma and academic institutions. Additionally, Raven managed all CLQ curation activity performed externally by Tempus and Concert.AI. In October of 2020, Raven joined Natera as Associate Director of Clinical Data Abstraction, where she is overseeing all data abstraction and management activity for the Oncology business unit. Raven is a member of six professional organizations, ACDM, ACRP, DAMA, PMI, SCDM, and SOCRA, and holds three professional certifications, ACRP-CP, CCRP, and PMP. Throughout the past ten years, Raven has participated in various non-profit organizations and initiatives and enjoys volunteering to support veterans, the elderly, and the homeless. Raven enjoys spending time with her family and fishing. Raven holds herself to high professional ethical standards and approaches each task with three principles she created to define her brand- “I will remain teachable, I will always be approachable and available, and finally, my success is measured by the success of my team and staff.”
	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.
	Magdalena Kozlowska Director, Clinical Data Management Group GSK Click to view biography Magdalena Kozlowska is working with GSK as a Director within Clinical Data Management group, division of DS&M. She is a leader with demonstrated history of working in the pharmaceuticals and CRO industry, with deep DM knowledge combined with business oriented acumen. Experienced with team building, recruitment, new DM biz development. Skilled in set up and maintaining clinical studies across all phases within many TAs, mostly oncology. Creative, passionate and dedicated expert with strong industry know how. Research professional with Masters degree focused in Pharmacy from Medical University of Warsaw and PhD student within eHealth field.
	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.
	Rachel Oakley Senior Director Cmed Click to view biography Rachel has 19 years’ experience in the clinical research industry, starting out in clinical operations, moving into Functional Service Provision (FSP), and since 2015 has been involved in the implementation, growth and oversight of Risk-Based Monitoring (RBM), including centralised monitoring. Rachel’s most recent focus was consulting with clients that wanted to either implement an RBM methodology, wanted to improve their existing RBM methodology, or wanted to employ technology to support their RBM methodology (mainly risk assessment and management tools, and KRI dashboards). Her current role is Senior Director of Centralised Monitoring at Cmed.
	Nina Reyes Manager Clinical Data Management IQVIA Click to view biography 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 RBM DMEG and hopes to get a lot of new insights and to bring, together with the other members of this strong group, RBM a step forward.
	Lorena Rodríguez Principal Clinical Data Manager Cmed 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.
	Helen Smith Senior Data Coordinator PHASTAR Click to view biography I have worked in Clinical Data Management for over 20 years, based in the UK. I started my working career as a nurse and moved into Data Management following my degree in Zoology and Psychology at Reading University. I have worked for CROs during this time and have gained a wide variety of operational study experience. I joined PHASTAR earlier this year and am relatively new to Risk-based Quality Management. I am really pleased to have the opportunity to join the RBM DMEG. I am looking to represent the company to explore how we can further our proactive and targeted approach to data cleaning and delivering high quality data. It is a great opportunity share knowledge and experience within the industry.
	Achilleas Zaras Sales Engineer eClinical Solutions Click to view biography Achilleas has 14+ years of experience in the software industry which involves providing Clinical Data Hub solutions for Pharmaceutical companies and biotech’s, managing software development teams, hands-on coding in Microsoft .Net platform as well as Business Intelligence Suites like QlikSense. Having enjoyed a progressive career in diverse roles including responsibilities of a Solutions Consultant, Team Manager, Software Engineer and Business Intelligence Analyst in various sectors like Banking, Retail and now the Pharmaceutical industry.