Conference Committee

ACDM21 Conference Committee

The Association for Clinical Data Management (ACDM) Annual 2021 Conference will take place in Edinburgh, Scotland. The Conference will be held at the Sheraton Grand Hotel from the 7th-9th March.

The ACDM21 Conference Committee are a group of volunteers from a wide range of organisations. They use their industry skills and expertise to pull the conference programme together and oversee the planning of ACDM21.

Conference Committee Members

Nicola Griffiths (Chair)
Senior Data Manager
SQN Clinical

Nickie has worked in the pharmaceutical industry for 18 years. She has held a variety of positions within the industry and has spent the last 6 years working in Clinical Data Management. Nickie has worked from both the CRO and the Sponsor side and has worked on clinical trials spanning the latest oncology drugs through to consumer healthcare and medical devices. Nickie has been a member of the ACDM for several years and has presented at the conference. Nickie joined the ACDM conference organising committee around 3 years ago and last year took on the role of chair.

Stephanie Hau
Manager, Clinical Data Management
Orchard Therapeutics Ltd

Stephanie started her career in clinical data management over 15 years ago on the Contract Research Organization (CRO) side of the industry. She has since then held various positions with increasing responsibility at CROs, pharmaceutical and biotechnology companies.

Stephanie has a comprehensive knowledge of databases from working on various clinical studies utilising pCRFs, ePRO and eCRFs (from study set up through to database lock) and has extensive experience in vendor oversight, working with FSP models and managing outsourced data management tasks. She has been exposed to a wide range of various therapeutic areas and is currently working on clinical studies within rare diseases where gene therapies are being utilised.

James McKenna
Lead Data Manager
PRA Health Sciences

James started his career in research just over 7 years ago working on a variety of academic studies in a number of roles, where he gained a passion for data management. He progressed to a senior position within a sponsor organisation, setting up and developing their data management department. This included leading a team to implement new EDC and ePRO technologies; a project which earned the second-place ‘innovation in data management’ award at 2020’s ACDM conference. James’s key interests include ePRO/eCOA, emerging technologies and decentralised trials.

Richard Munday
Business Manager
University of Southampton

Richard has worked in clinical research for the past ten years from working in many NHS Trusts & UK Universities. Now he leads a team of highly skilled and super qualified, sought after individuals delivering high-quality, high-impact full, data services to the clinical trial community. He is privileged to work on many multinational and multicentre studies across the globe, notably trials he has supported in New Zealand. Richard currently works for the Clinical Informatics Research Unit (CIRU) at the University of Southampton, that provide EDC, randomisation, data management, drug supply management, training, and statistical support and lots more. He has quoted over £2.5m of work over the last few years within the unit. He has seen exponential growth, starting from a team of one, now a team of six following a considerable increase in sales and exposure over the last four years.

Hari Priya
Clinical Data Sciences Lead
Merck Group

Priya started her career in Clinical Data Management for a little more than 12 years ago. She has held a variety of positions at Pharmaceutical companies, CROs and Pharma BPO&Consulting, with increasing responsibility that expands to SDTM & Clinical Data Analytics. In the recent past, she led an initiative to develop strategies for future roles in Clinical Data Sciences. She is associated with various volunteer organizations like CDISC and Pinnacle21 wherein she is actively involved in creating clinical data standards and ensuring that submission data is compliant to regulatory agencies . With her ongoing contribution in developing the Data Decision Metrics and Analytics she was identified as Co-Lead for “CDM Metrics & Analytics” DMEG at ACDM.

She is an active Conference Committee member and conducts hot topic discussions, webinars and manages newsletters and publications.

Ali Roskell
Clinical Data Manager
Vitaflo International Ltd

Ali works within the Clinical Operations team at Vitaflo International Ltd as Clinical Data Manager and is responsible for all aspects of data management for the Vitaflo clinical trial portfolio. She works cross functionally with internal and external study stakeholders to ensure that data management procedures and deliverables are met and performed in accordance with Good Clinical Practice (GCP) and current regulatory and ethical requirements.

Ali has a wealth of clinical research experience having begun her data management career in 1996 and has previously worked in various data management roles in the pharmaceutical industry, academia, NHS and more recently for a specialised data management and biometrics Contract Research Organsiation (CRO).

Ali has been involved in the ACDM for many years, initially as a newsletter committee member, then Newsletter Editor and Chair. Ali joined the conference committee in 2009, and apart from a short break, has been involved since.

	Nicola Griffiths (Chair) Senior Data Manager SQN Clinical Click to view biography Nickie has worked in the pharmaceutical industry for 18 years. She has held a variety of positions within the industry and has spent the last 6 years working in Clinical Data Management. Nickie has worked from both the CRO and the Sponsor side and has worked on clinical trials spanning the latest oncology drugs through to consumer healthcare and medical devices. Nickie has been a member of the ACDM for several years and has presented at the conference. Nickie joined the ACDM conference organising committee around 3 years ago and last year took on the role of chair.
	Stephanie Hau Manager, Clinical Data Management Orchard Therapeutics Ltd Click to view biography Stephanie started her career in clinical data management over 15 years ago on the Contract Research Organization (CRO) side of the industry. She has since then held various positions with increasing responsibility at CROs, pharmaceutical and biotechnology companies. Stephanie has a comprehensive knowledge of databases from working on various clinical studies utilising pCRFs, ePRO and eCRFs (from study set up through to database lock) and has extensive experience in vendor oversight, working with FSP models and managing outsourced data management tasks. She has been exposed to a wide range of various therapeutic areas and is currently working on clinical studies within rare diseases where gene therapies are being utilised.
	James McKenna Lead Data Manager PRA Health Sciences Click to view biography James started his career in research just over 7 years ago working on a variety of academic studies in a number of roles, where he gained a passion for data management. He progressed to a senior position within a sponsor organisation, setting up and developing their data management department. This included leading a team to implement new EDC and ePRO technologies; a project which earned the second-place ‘innovation in data management’ award at 2020’s ACDM conference. James’s key interests include ePRO/eCOA, emerging technologies and decentralised trials.
	Richard Munday Business Manager University of Southampton Click to view biography Richard has worked in clinical research for the past ten years from working in many NHS Trusts & UK Universities. Now he leads a team of highly skilled and super qualified, sought after individuals delivering high-quality, high-impact full, data services to the clinical trial community. He is privileged to work on many multinational and multicentre studies across the globe, notably trials he has supported in New Zealand. Richard currently works for the Clinical Informatics Research Unit (CIRU) at the University of Southampton, that provide EDC, randomisation, data management, drug supply management, training, and statistical support and lots more. He has quoted over £2.5m of work over the last few years within the unit. He has seen exponential growth, starting from a team of one, now a team of six following a considerable increase in sales and exposure over the last four years.
	Hari Priya Clinical Data Sciences Lead Merck Group Click to view biography Priya started her career in Clinical Data Management for a little more than 12 years ago. She has held a variety of positions at Pharmaceutical companies, CROs and Pharma BPO&Consulting, with increasing responsibility that expands to SDTM & Clinical Data Analytics. In the recent past, she led an initiative to develop strategies for future roles in Clinical Data Sciences. She is associated with various volunteer organizations like CDISC and Pinnacle21 wherein she is actively involved in creating clinical data standards and ensuring that submission data is compliant to regulatory agencies . With her ongoing contribution in developing the Data Decision Metrics and Analytics she was identified as Co-Lead for “CDM Metrics & Analytics” DMEG at ACDM. She is an active Conference Committee member and conducts hot topic discussions, webinars and manages newsletters and publications.
	Ali Roskell Clinical Data Manager Vitaflo International Ltd Click to view biography Ali works within the Clinical Operations team at Vitaflo International Ltd as Clinical Data Manager and is responsible for all aspects of data management for the Vitaflo clinical trial portfolio. She works cross functionally with internal and external study stakeholders to ensure that data management procedures and deliverables are met and performed in accordance with Good Clinical Practice (GCP) and current regulatory and ethical requirements. Ali has a wealth of clinical research experience having begun her data management career in 1996 and has previously worked in various data management roles in the pharmaceutical industry, academia, NHS and more recently for a specialised data management and biometrics Contract Research Organsiation (CRO). Ali has been involved in the ACDM for many years, initially as a newsletter committee member, then Newsletter Editor and Chair. Ali joined the conference committee in 2009, and apart from a short break, has been involved since.