ACDM24 Conference Committee

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.

A highly skilled leader with extensive Clinical Data Systems and Data Management experience from working in a large Contract Research Organisation, Pharmaceutical company, and academic Clinical Trials Unit. Decisive and proficient in leadership and management, including building, coaching, and motivating teams; with a professional and calm approach in times of pressure. Extensive project management of large multi-national and small studies, across a wide range of therapeutic areas and clinical phases; demonstrating good internal and international collaborative approaches whilst adhering to ICH and GCP Guidelines.

Experience of introduction of new systems and systems migration with stakeholders nationally and globally, with consideration for Business Continuity, Information governance, IT Security, Audit and Quality management.

Chair of the UK CRC Information Systems Operational Group.

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 including oncology, infectious diseases, immunology, neuroscience and rare diseases (utility gene therapies) within data management.

Angie Major is the Managing Director and co-founder of Delegant. Angie has over 20 years experience within membership associations and event management. Angie held the position of Membership Development Manager with the Institute of Clinical Research during the early 2000s and was instrumental in the restructure of the membership levels and running of Committees, member focussed events in the UK and across mainland Europe. 

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.

Jas has over 25 years in the life sciences and clinical technologies – particularly within clinical systems, linked to data collection and management. Having started his career as a data manager when clinical trials were predominantly done on paper, Jas has seen the industry evolve and develop over the years and gained a deep understanding and experience of working with most eClinical / CDMS solutions used in the industry and end to end clinical trial processes. Currently, Jas follows keenly the influence of omics data and its impact on clinical trials of the future and precision medicine.

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 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.