2022 Faculty

Niharika Anand, MBA
Regional Director
APAC at TriNetX, Australia

Niharika completed her BSc (Hons) in Neuroscience and Biochemistry from the University of Melbourne and subsequently started working for Alfred Hospital as a Clinical Study Coordinator. Inspired by clever science that promises compelling solutions to real-world problems, Niharika found her focus to be on technology to help advance research. This prompted her to complete her MBA in 2020 focusing on technology and operations. Taking on various clinical development and management roles with Amgen, Australia, and IQVIA. Niharika is currently the APAC Regional Director for TriNetX. A Boston- based real-world data company that is changing the way research is being done globally. Focusing on using data, machine learning, and AI to allow healthcare organisations to leverage their data and empower themselves to create change in the existing landscape.

Rupi Bancil
VP of Global Expansion and DCT Operations
Care Access, UK

Rupi Bancil is the Vice President of Global Expansion and DCT Operations at Care Access. She started her career at PAREXEL and then moved to Synexus Clinical Research (later part of PPD), where she led site operations, feasibility, project management, operational compliance, and global patient recruitment teams. Rupi is passionate about using patient-centric approaches to make research more accessible to diverse communities around the world. She holds a Bachelor of Science degree in Biomedical Sciences from Brunel University London.

Jimmy Bechtel, MBA
Vice President, Site Engagement
SCRS, USA

Jimmy Bechtel is the Society for Clinical Research Sites’ (SCRS) Vice President, Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Mr. Bechtel provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter and operations manager. On the pharma side where he worked in innovation project management, Mr. Bechtel utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Mr. Bechtel to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Mr. Bechtel is in charge of developing and executing the company’s site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. He also manages some of SCRS’s large industry initiatives that are based on innovative concepts and helps oversee the organizations membership.

Emily Blyth, BN, BMid
Trial Advancement Team Manager
Emeritus Research, Australia

Trial Advancement Specialist with experience in all aspects of study start up, including HREC/IRB submissions, budget and contract negotiations and essential documents. Experienced Clinical Research Coordinator with a demonstrated history of working in the pharmaceuticals industry. Skilled in Clinical Research, Data Entry and Clinical Trials. Strong healthcare professional with a Bachelor’s degree in both Nursing and Midwifery from Deakin University.

Charlotte Bradshaw
CEO and Founder
Evrima, Australia

Experienced patient recruitment specialist with strong project management and digital marketing expertise across various therapeutic areas and trial phases. Client-focused and driven to achieve innovative solutions.

Chris Brooks, RN, CCRN, BaAppSc (Nursing) Grad Cert (Crit. Care)
Research Manager
Alfred Health, Australia

Katrina Brosnan, RN, ICU Cert, BN
Principal Policy Officer
Queensland Health, Australia

Katrina trained as a Registered Nurse, specialising in Critical Care, and had twenty years experience in the clinical environment before moving into research.

Since 2001, she has worked in research across various roles – starting as a clinical research coordinator, initially in transplant research, then dementia clinical trials.  She has worked as a Research Governance Officer, and as an Ethics Administrator before accepting the role of Principal Policy Officer in the Office of Health and Medical Research (now OPMR) in the Queensland Department of Health in 2009.  Since then, Katrina has undertaken intermittent short term contracts back in the health service environment so as to maintain currency of practice in clinical research coordination (cardiology trials and acute stroke trials), and research ethics and governance. In January 2021, Katrina joined the national office of the Australian Teletrial Program, based in Queensland Health.

Radhika Butala
Manager- Medical Oncology Clinical Trials Unit
Westmead Hospital, Australia

Radhika is a passionate Clinical Researcher and Site Advocate with over 17 years of experience and expertise from Trial Coordination to Trial Unit establishment. She has diverse clinical trial expertise in interventional and device studies spread across multiple therapeutic areas like oncology, cardiovascular, urology, neurology, immunotherapy, dementia and audiology. She has operational and managerial experience in the public, private, commercial and academic sectors within the clinical research industry and the Australian Healthcare sector. She is the current Manager of Medical Oncology Clinical Trials Unit (MOCTU) at Westmead Hospital, Sydney and has been a founding member and Summit Steering Committee member of SCRS Asia-Pac since 2014.

Carolyn Casey, LLB
Chief Operating Officer
Paratus Clinical Research, Australia

Carolyn has worked in clinical trials since 2002 within the public hospital system, industry, and now private sites. A lawyer specialising in clinical trial compliance, regulation and quality, Carolyn has consulted to a number of sponsors in regard to their clinical trial regulatory obligations. She has trained clinical trial teams in this regulation and compliance, in particular ICH GCP. Carolyn understands the clinical trial process from initial review to final reporting, having sat as Secretary of various research committees including Human Research Ethics Committees, Animal Ethics Committees, and Institutional Biosafety Committees. After serving on the Paratus Board since inception, Carolyn now leads Paratus in the operation of all clinical trials across our four sites.

Mia Castagnero
Business Development Manager
Clinical Research IO (CRIO), Australia

Mia brings experience from both the vendor and site sides of the clinical research industry. Leading international site sales at CRIO, Mia helps to equip sites with a software that replaces antiquated paper-based data collection processes. CRIO provides a powerful eSource, eRegulatory, eConsent and CTMS solution. Prior to CRIO, Mia worked at a site network conducting Phase II-IV clinical trials.

 

Maria Cecilia L. Castillo
Senior Director Audit Management, Quality and Compliance
PPD, part of Thermo Fisher Scientific, Australia

Cecilia is a wife and mother to three beautiful children and consider her family as her greatest blessing and source of motivation.

She lost her father to cancer as a teenager and right about when she entered university in the early nineties. It was at a time when there were very limited treatment options available for Acute Lymphocytic Leukemia. Having realized the impact of this situation, it motivated her to pursue a degree in Pharmacy and later on join the clinical research industry, first as a study coordinator, then as a CRA, and now in Quality. This work is personal, knowing her job can help patients and their families enjoy life to the full.

She is currently the global head of Audit Management, leading Quality professionals spread across 20+ countries, delivering best in class drug development services to Pharma, Biotech, and Government clients in PPD (part of Thermo Fisher Scientific).

She is known for collaborative leadership, leading change and transformations, and consistent delivery of business targets.

Her goal is to have continuous development professionally and in personal life; influence people around her to find meaningful purpose in life, passion for excellence, and serve others.

Anna Chen, PhD, MA
Senior Recruitment Project Manager
Opyl, Australia

Dr Anna Chen is currently the Senior Clinical Recruitment Project Manager at Opyl. Anna has a background in medical research with a PhD in cancel cell biology from the University of Melbourne, and media and communications. At Opyl, Anna has a key role in delivering services through the platform Opin, providing digital solutions in the space of clinical trial recruitment.    

Patricia Church
Site Excellence Partner
Pfizer, Australia and New Zealand

 

Trish has worked across most areas of Clinical Research in the 20+ years she has spent in the industry. She enjoys supporting the training and development of clinical research staff and promoting quality and inspection readiness. In the past 10 years Trish has represented the Sponsor at both FDA and EMA inspections in Australia and Europe.

Matt Clacy, MBA
Chief Commercial Officer
Paratus Clinical, Australia

Matt has worked in the medical and clinical research industry since 2000 across Asia Pacific, Europe, and North America, holding positions of increasing responsibility in business development and commercial leadership. In 2015 he was a Co-Founder of Paratus Clinical, an Investigator Site Network, he sought and attained funding to establish and develop the business of which he is a Director and Chief Commercial Officer. 

Rebecca Clarke
Senior Operations Manager-Research Coordination
Icon Group, Australia

Rebecca has 10 years’ experience in the clinical research space having held numerous roles across quality, governance and operations. With a strong interest in Phase I-IV oncology trials and dedication to improving the execution of trials, Rebecca leads Icon’s research coordination with efficiency. Managing an experienced team, she is focused on improving planning and execution of a national clinical trials program whilst maintaining the highest quality.

Jennifer Cranefield, RN, BNur,  MHlthSc (HlthServMgmt), CCRC
Nurse Consultant/Manager
Royal Adelaide Hospital, Australia

Jennifer is one of Australia’s most experienced stroke trials co-ordinators with more than 12 years Stroke Trials experience. She has been involved in both acute stroke research and stroke epidemiology research. Jennifer is on the Executive of the Australasian Stroke Trials Network and has close relationships with Stroke coordinators throughout Australia and New Zealand.

She has personally been at the forefront of recruiting and retaining patients into the pivotal ischaemic stroke thrombectomy/tenecteplase trials with her site being one of the top 2 recruiters for these studies. Her experience and expertise in site readiness and recruitment has led some CRO and Sponsors to ask her to support less experienced sites during the start-up phase and beyond.

She has developed a sound working knowledge of trial datapoint design, data collection, data management and trial coordination. Her site has been audited (because of excellent international recruitment for studies) and her work has been commended for its thoroughness and meticulousness.

Jacqueline Dixon, RN
Program Manager-Teletrials
Alfred Health, Australia

Jacqueline is a registered nurse with diverse experience in health care service and health care delivery models.

Her breadth of experience is expansive at both strategic and operational levels and encompasses the full spectrum of health care delivery- from primary health care through to large public and private institutions.

Jacqueline has been instrumental in working with primary health care organisations to implement and facilitate the translation of public policy into practice -particularly in the application of novel digital technologies in health care practice.

Operational clinical trial experience has been across a range of disciplines and therapeutic areas and includes trial phases 1 to 4, conducted in both the acute health service and community sectors.

Most recently this experience has been in with TrialHub at Alfred Health in Melbourne, Australia.

It is in this context that Jacqueline has had the opportunity to focus on the implementation of teletrials as a delivery model for complex early phase clinical trials and collaborative group studies. A key achievement in this area has been the first medical oncology phase 1 clinical trial to be implemented as a teletrial globally. This achievement was recognised in a Leading Innovation & Change in Clinical Trials excellence award for the team at Alfred Health.

Jacqueline continues her interest in the application of novel digital technologies in the clinical trial field particularly in the areas of teletrials and decentralised clinical trial models.

Shanny Dyer, PhD
Chief Executive Officer
ARCS Australia

Shanny is an experienced senior executive, having held roles across industry, government and universities. She has expertise in public administration and policy development with strong corporate governance skills. Shanny holds a PhD in Biochemistry and is a graduate of the Australian Institute of Company Directors.

Brayden Fraser, MSc
Chief Development Officer
Emeritus Research, Australia

Brayden has worked at Emeritus Research for 2 years within a variety of roles in the Recruitment and Trial Advancement Teams most recently as the Recruitment Manager. Currently as the Chief Development Officer he manages the Recruitment, Trial Advancement and Business Development departments. He has a passion for science and clinical research and holds a Masters of Science from the University of Melbourne where he studied small metabolites within endometriosis tissue using mass spectrometry techniques.

 

Claire Gibson
Associate Director, Regulatory & Start-Up (ANZ)
IQVIA, Australia

Claire Gibson is the Associate Director of Regulatory and Start-up (ANZ) at IQVIA. She leads the team across Australia and New Zealand from feasibility to site activation, to ensure quality and efficient delivery so that ANZ patients have access to life changing treatments. Claire has been in the industry over 15 years, working with Sponsors and CRO’s, in various roles from Clinical Research Associate (CRA), Start-up Specialist and Clinical Line Manager. She has been instrumental in many initiatives, piloting new ideas & striving to improve the way we all work together. She is passionate about collaborating, learning and championing people.     

Rick Greenfield
CEO
RealTime Software Solutions, USA

 

Rick Greenfield is the CEO of RealTime Software Solutions, a leading Clinical Trial Management Systems provider. Rick also co-owned and managed one of the largest multi-specialty research sites in the US for nearly thirteen years where RealTime-CTMS was first created and implemented to streamline site operations for all staff and processes. Today, RealTime is the only CTMS vendor that can offer the industry-leading site SOMS (Site Operations Management System) that fully integrates CTMS, TEXT, PAY, eDOCS and eSOURCE, and includes a convenient Mobile App that puts the entire SOMS system into the hands of research clinicians and investigators. RealTime will soon be launching a one-of-a-kind, global participant portal “MyStudyManager” that will allow sites to engage with their study volunteers on numerous levels, to include eCONSENT, virtual visits, satisfaction surveys, ePRO and more.

Cheryl-Ann Hawkins, RN, MHA
Chief Operating Officer
Emeritus Research, Australia

Cheryl-Ann Hawkins is the Chief Operating Officer at Emeritus Research.  Cheryl-Ann has enjoyed working in many leadership positions in both Clinical Trials and Oncology in a career spanning 30 years.  She is an efficient end to end specialist with expertise in Oncology and first in human drug trials, including immunotherapy and GMO’s.  Cheryl-Ann is focused on the practicalities of protocols and the impact on resources at site level.  Cheryl-Ann has interest in the implementation of innovative approaches of clinical trial delivery to ensure optimal efficiencies at site level.  Cheryl-Ann is solutions oriented and thrives in the challenging clinical trial environment to ensure success for both sponsors and clinical trial participants.  She also believes in and supports, the professional development of staff to ensure they reach their full potential. Cheryl-Ann is a Registered Nurse with a Bachelor of Nursing,  has completed a post graduate diploma in Oncology/Palliative care nursing, a Master’s degree in Health Administration and a post graduate certificate in Cancer Research.  She has had the opportunity and privilege to educate students studying clinical trials at both Monash and Melbourne Universities.  Cheryl-Ann is the current Co-chair of SCRS Asia Pacific site solutions summit organising committee, as well a member of ARCS 2022 Annual Conference Advisory Panel.

Sonia Harvey
Project Manager
CT:IQ, Australia

Sonia has a wealth of experience in project management across the health and medical research, oil and gas, retail and agricultural sectors. Sonia joined CT:IQ in 2019, a member-based organisation focused on improving the impact, quality and efficiency of clinical trials in Australia. Sonia manages key clinical trial sector projects, delivering to date an Early Phase Best Practice Checklist and a Clinical Trial Site Recruitment Guide. Sonia’s current project is a challenging one, managing a project team of 40 people from CT:IQ member organisations, aiming to transform Australian informed consent templates to create much shorter, simplified, more respectful participant information and consent forms that people can understand, allowing them to make a truly informed decision whether to participate in research.

Stephanie Henderson, BSc (Hons)
Senior Start-Up and Site Specialist
Cancer Trials, Australia

Stephanie is a Senior start-up and Site specialist at Cancer trials Australia, and has Stephanie has handled HREC submissions on behalf of multiple sites including Pete consent forms. Currently she helps to oversee ethics and governance submissions on behalf of Western Health and the Parkville Cancer Clinical Trials Unit. 

Taneen Hisgrove, MAICD
Executive Director, Patient Solutions
PPD, part of Thermo Fisher Scientific, Australia

My passion is to make the world heather by bring potentially life-saving or life changing medication to market faster. I  am privilege in my role to have the platform to engage and collaborate with the site community globally and locally, to have time to listen and understand the challenges that will allow industry to work together to find solutions to support sites and expand patient’s access to clinical trials. I truly believe that ” Patient centricity starts with Site Centricity”  

 

Kathleen Irish, MS
Manager of Clinicaltrials NSW
NSW Office of Health and Medical Research, Australia

Kath is the Manager of clinicaltrialsNSW, NSW Office for Health and Medical Research. Kath has worked in clinical trials for 25 years, exclusively at sites before moving to the NSW Health Clinical Trials Support Unit in the Ministry of Health in 2021. She has worked in Adult and Paediatric units, in Public, Private and Public Private Partnership hospitals, in local, national, and international trials from Phase I through Phase IV. Having worked in sites for most of her career, Kath has a dedication to supporting and representing site staff as key stakeholders in the clinical research sector. Kath has taken secondments to a Local Health District CTSU, and to a Local Health District Research Office. Kath has recently finished a term as Deputy Chair of an Institutional Human Research Ethics Committee. Kath studied a Bachelor of Science, with a major in Applied Mathematics and Statistics; and has a Master of Studies. She is currently pursuing her passion for Human Rights and studying a Master of Human Rights (Social Policy specialisation).

Amy Ives, MPhil, RN
Manager, Medical Oncology Trials Cancer Care Services
Queensland Health, Australia

Amy Ives is the Manager of the Medical Oncology Trials team in the Clinical Research Unit, Cancer Care Services at the Royal Brisbane & Women’s Hospital in Brisbane. An RN for over 20 years, she moved with her family from the US to Brisbane in 2002 and has been with the trials team since 2011. Amy has a Graduate Certificate in Clinical Trials Practice from the University of Sydney & is currently enrolled in a Master of Philosophy at the University of Queensland. She is a passionate advocate for clinical trials and believes trials should be embedded into patient care. In her spare time Amy enjoys reading, collecting sea glass, and eating far too much chocolate.

Mark Johnson, EMBA,BEng, BInfTech, CPEng
Chief Operating Officer
Clinibase, Australia

Mark has more than a decade’s management experience implementing large scale systems. He is a highly capable Chartered Systems Engineer recently awarded the Engineers Australia – Neville Thielle Award for eminence in information, telecommunications and electronics engineering. Mark is highly qualified with an Executive Masters of Business Administration, Bachelor of Microelectronic Engineering and Bachelor of Information Technology. Over the past few years, Mark has applied his systems and business optimising skills to improve clinical trial site performance using technology. This has resulted in implementing more than a dozen clinical trial site solutions tailored to address the unique way Australian clinical trial sites operate.

 

Arianne Jolly
Clinical Research, Site Relationships
Pfizer, Australia

Arianne brings over 20 years of Clinical Research Experience within the Medical Device and Pharmaceutical industries, where her responsibilities have included designing, implementing and managing clinical studies that align with strategic goals and comply with regulations at both a local and international level.

Arianne has worked across all phases of clinical research and managed and developed clinical studies across both pharmaceutical and medical device disciplines. This has included collaboration with corporate head offices and working closely with KOLs to develop protocols within their interest areas.

Arianne is a structured, dedicated, motivated individual with a passion for clinical research. Her focus on quality and meticulous attention to detail have allowed her to develop into a role of SOP creation and implementation of Clinical Research Quality systems, which have created a high quality approach to clinical trials that are fully aligned with regulatory, ethical and legal requirements within the global research environment.

Christy Kelln, MS
Vice President, Site Conduct 
Care Access Research, USA

Christy Kelln is the Senior Vice President of Site Conduct at Care Access where she oversees over the site network and all related support functions including source, regulatory, training, and site development. For the past two decades, Christy has led national and global site expansion efforts and incorporated advanced technologies to support study enrollment. She is adept at building professional and collaborative relationships with study personnel, sponsors, vendors and other stakeholders, and is known for her commitment to safety, quality and exceeding financial goals. Christy holds a Master’s degree in Physical Anthropology from the University of Montana and a Bachelors in Anthropology from Indiana University.

Robert Kent, RN
Research Operations Manager
The Kinghorn Cancer Centre, Australia

Providing operational and strategic management to the Kinghorn Cancer Centre.
Specialising in Phase I-III research in Advance and Rare Cancer, General Oncology and Haematological diseases.

Rachelle Kirk-Burnnand
Head of Clinical Operations
Neuroscience Trials Australia

Anna Lam, MVM
Country Head for Clinical Operations
Janssen-Cilag, Australia & New Zealand

Anna has nearly 20 years of experience working in R&D, starting as a laboratory scientist before moving to clinical research as a CRA and progressing through various roles in the medical device and pharmaceutical sectors. Her experience includes clinical trials in oncology, endocrinology, immunology, and surgical specialties such as orthopaedics, biologicals/ haemostasis and neurosurgery. Anna is currently the Country Head for Clinical Operations at Janssen-Cilag. In this role, she leads a team of 100 plus operations staff who set-up and execute approx. 60 Phase I-III Global trials at any one time across Australia and New Zealand.

Bill Lam, PhD, MBChB
Senior, Director, Clinical Site Operations
Pfizer, Australia & New Zealand

Biopharmaceutical professional with greater than 20 years of experience in international drug development from early clinical development to launch, commercialization and achieving access & reimbursement – on a background of clinical medicine & basic science research. This experience stemmed from a broad-based role in Pfizer Australia, in which the capabilities of a multi-disciplinary team of medical affairs, marketing, clinical operations, regulatory affairs, pharmaco-economic, legal & corporate affairs specialists were harnessed to grow the pharmaceutical business. This model formed the basis of a subsequent Japan/Asia Regional Medical role, and has been further developed in the current position in Emerging Markets Development at Pfizer HQ.

Adrian Lanzillotti
General Manager
Clinibase, Australia

Adrian Lanzillotti has worked in clinical trials for the last 4 years specialising in recruitment. Having spent 3 and a half years as the Associate Director of Recruitment at Nucleus Network, Adrian joined Clinibase to lead the recruitment team and help drive the performance and standards that made him a success at Nucleus Network.         

Marian Lieschke, RN
Clinical Trials Manager
Parkville Cancer Clinical Trials Unit, Peter MacCallum Cancer Centre, Australia

Marian Lieschke trained as an Oncology Nurse at the Royal Marsden. After moving to Australia, she worked extensively as a Clinical Oncology Research Nurse becoming the the Manager of the Royal Melbourne Hospital Oncology Clinical Trials Unit in 2004. She was appointed as the Manager of the Parkville Cancer Clinical Trials Unit (PCCTU) in 2016, bringing the trial units of RMH , the Peter MacCallum Cancer Centre and the Royal Women’s Hospitals together as a single unit to serve the Precinct, a unit which now employs nearly 100 staff. Marian has held positions in the Victorian Association of Research Nurses and the Cancer Council of Victoria Clinical Trials Professionals Group and currently chairs the VCCC committee on Building Workforce Capacity. Marian is passionate about Clinical trials as an alternate clinical pathway for patients, about education for Clinical trial staff and for improving the Clinical trial industry by increasing conversation with global Pharmaceutical companies.

Lucas Litewka, BaAppSci, MBA 
Director, Clinical Trials Centre
University of Sunshine Coast (USC), Australia

Lucas joined the University of the Sunshine Coast (USC), as the inaugural Director of the Clinical Trials Centre in 2015. The primary focus of this role was to take a greenfield opportunity and create an industry-focused Clinical Trials Centre on the Sunshine Coast and extend the network across Queensland. He has a sound understanding of the hospital, health, university and research sectors, along with the ability to understand and interpret government policy to align with the organisation’s business strategy. 

Marie Luci, BSc(Biomed), GradDipHealthEco, MMSc, 
Operations Manager
Cancer Trials Australia

Paula Mackie
Country Clinical Quality Manager (CCQM) Lead
MSD, Australia and New Zealand

Paula is the Country Clinical Quality Manager (CCQM) Lead for Australia and New Zealand at MSD Australia. She is an experienced clinical research professional, having worked in the industry for > 25 years.  Paula has held various Clinical Operational, Training and Quality roles during her career, and has worked for both CRO and Pharmaceutical companies. Paula prides herself on taking a practical, risk-based approach to quality management, while constantly seeking continuous improvement.

She has experienced both FDA and EMA Site Inspections in Australia, as well as several Sponsor led GCP Site Audits. Since 2020, this has included several remote Site GCP audits. 

Paula holds a Bachelor of Science in Biochemistry and Physiology from The University of New South Wales, and a Graduate Diploma in Drug Evaluation & Pharmaceutical Science from The University of Melbourne in Australia.

Rebecca Maxwell
Associate Director, Clinical Operations
PPD, part of Thermo Fisher Scientific, Australia

Rebecca Maxwell is the Associate Director for Clinical Operations at PPD, Part of Thermo Fisher Scientifica, a position where she actively leads and oversees all study start up activities for Australia. Rebecca has been involved in the clinical research Industry for over 17 years in various roles include Site Coordinator, Start- Up Specialist, People Manager and FSP Portfolio Manager. Before joining PPD in 2015, she was involved in clinical research in Ophthalmology at the Centre for Eye Research Australia.
While at PPD, Rebecca has worked to support significant business and headcount growth within the Australian Start Up Team. Working regionally and globally on initiatives to transform our start-up processes to continue to support new business opportunities into the region.

Jenny McGrath, RN, MS, ACRP
Clinical Research Project Lead
Royal Adelaide Hospital, Australia

Clinical Research Project Lead (ACRP Certified) Respiratory Clinical Trials Unit, Thoracic Medicine, Royal Adelaide Hospital.  Jenny has an extensive background in Clinical Research having worked at the RCTU for over 20 years. As a Registered Nurse these qualifications compliment her research achievements (Masters in Science – Research) and she is a valuable resource for all RCTU staff. Jenny is part of the senior management team in RCTU.
Her initiatives to RCTU and the running of the Unit include:
Training and education of Clinical Research Coordinators (CRC) in ICH GCP, Respiratory diseases, Respiratory therapies and their uses as well as study software during the course of studies. Jenny is instrumental in creating business opportunities and is central to the Ethics and Governance of the RCTU as well as a resource to other units within CALHN. Jenny has been instrumental in bringing a Clinical Trials Centre to the new RAH and a Clinical Trials Management System to CALHN.

Fiona McIlroy
Country Trials Manager
Pfizer, Australia

Sophie Mepham, PhD
Group Executive Manager, Research
Icon Group, Australia

Sophie has worked in oncology clinical research for over 20 years, specialising in research that focuses on Theranostics, medical oncology, haematology and radiation oncology. Sophie is currently the Group Executive Manager for Global Research at Icon Group, responsible for oncology clinical trials at Icon sites across Asia Pac. Prior to this role, Sophie worked as the National Research Manager at GenesisCare, and as Senior Manager, Translational and Clinical Research and Head of the Clinical Trials Unit at Peter Mac, covering all specialities of oncology trials, from first in human, through to phase III. Before moving to Australia in 2012, Sophie worked in the UK managing a haematology clinical trials unit for 8 years and then subsequently for 2 years as a Research & Development Manager for all clinical research across a large NHS hospital as part of the National Institute for Health Research (NIHR). She has a PhD in Oncology/Immunology and is an NIHR accredited GCP trainer and GCP program lead.

 

Melissa Montealegre
Head of Site Management and Monitoring
MSD, Australia

With over 17 years’ experience in Clinical Research, Melissa is currently one of the CRA Managers leading a team of Clinical Research Associates/Senior CRAs at MSD Australia and New Zealand.

As a People Leader, Melissa is responsible for the CRA teams’ deliverables, quality performance and resource allocation. In addition to developing key talent, Melissa is also an advocate for team culture and collaboration. In the height of the COVID-19 pandemic, Melissa initiated the GCTO Ambassadors Program which kept the team’s connection and engagement and supported the virtual/hybrid working environment amid the restrictions brought about by the lockdowns.

Based in Melbourne, Melissa holds a Postgraduate Diploma in Pharmaceutical Sciences from the University of Auckland, NZ.

Scott Needham
CEO
Leading Technology, Australia

Scott Needham is the CEO and majority owner of Leading Technology Group Pty Ltd (LTG), a private investment company with a primary focus on health, life sciences and technology businesses.

Tam Nguyen, PhD, MBA
Associate Professor, Deputy Director of Research
St. Vincent’s Hospital Melbourne, Australia

Associate Professor Tam Nguyen has over 20 years of working in clinical trials, health and medical research and research management sector including tertiary teaching hospitals, medical research institutes and universities across Australia.

Tam is the deputy director of research at St Vincent’s Hospital Melbourne, responsible for research strategy, research development and innovation. Tam serves as non-executive director and advisor to several medtech and health tech start-ups and scale ups.

He holds academic appointments with Melbourne Medical School, Monash Medical School and RMIT University and is a Fellow of the Royal Society of Public Health, Australian Institute of Managers and Leaders and Australasian Research Management Society.

Tam is a co-editor of a recently published book– Artificial Intelligence in Medicine (by Springer Nature).

 

Skye Nolan, MPH, MS
Clinical Trials Business Improvement Lead
Monash Health, Australia

Skye has over 10 years working in health research and has spent the last 7 years working in clinical research at Peter MacCallum Cancer Centre, Monash Children’s Cancer Centre, Epworth Health Care, and Icon Cancer Centre. She is currently at Monash Health working in the Research Support Services team to implement the National Clinical Trials Governance Framework across the organisation. She has an interest in creating change in the sector through embracing technology and improving processes.

 

Trina O’Donnell, BSc, Grad Dip Bus
Operations Manager
Belberry Limited, Australia

Trina O’Donnell is the Operations Manager at Bellberry Limited.

Bellberry is a national, private not-for-profit organisation providing streamlined scientific and ethical review of human research projects across Australia. As a not for profit company, Bellberry donates surplus funds back into the research community.

Trina has degrees in science and business.She started her career in the public sector as a Patent Examiner, and then in policy development with the Department of Industry Science and Technology. Moving to the private sector Trina has mainly worked in the pharmaceutical industry across a range of areas including intellectual property management, regulatory affairs, drug development and sourcing, auditing, and business development. She has been with Bellberry for over ten years supporting research ethics submissions and processes.

 

Casey Orvin
Chief Commercial Officer
CenExel Centers of Excellence, USA

Casey Orvin is CCO at CenExel. With nearly 20 years of experience working with the site community, Orvin previously served as President of the Society for Clinical Research Sites (SCRS), Executive Vice President of Business Development for Synexus, and Vice President of Marketing and Sponsor Recruitment for Clinical Research Advantage. Orvin is a champion for clinical research sites with experience creating outreach programs, developing key partnerships, and generating study opportunities for hundreds of clinical research sites globally. He is an active community member and dedicated volunteer in the Phoenix area where he lives with his wife and three children.With nearly 20 years of experience working with the site community, Orvin previously served as Executive Vice President of Business Development for Synexus, and Vice President of Marketing and Sponsor Recruitment for Clinical Research Advantage. Orvin is a champion for clinical research sites with experience creating outreach programs, developing key partnerships, and generating study opportunities for hundreds of clinical research sites globally. He is an active community member and dedicated volunteer in the Phoenix area where he lives with his wife and three children.

Kate Rabel
Clinical Research Associate
Novotech, Australia

Kate commenced her career in the clinical trials industry at Emeritus Research, where she worked as the Clinical Trial Recruitment Team Leader and was responsible for the development and implementation of recruitment campaigns across a vast range of therapeutic areas and clinical trial phases. She has recently joined Novotech as a Clinical Research Associate.

Amanda Rangel, MS, CCRC
Senior Vice President, Business Development
Total Diversity, USA

Amanda is well established and an expert in building relationships within the clinical trials industry. Her broad skill set covers business development, marketing, patient recruitment and operational roles within various organization types, including small sites, large global site networks, CROs, technology providers and startups.

Amanda has dedicated her career to improving the quality and efficiency of clinical trial conduct. Before Total Diversity, Amanda served as executive vice president of business development for VirTrial, a leading telehealth and decentralized clinical trial (DCT) platform provider designed specifically for clinical trials. Anticipating the need to support DCTs at the site level well in advance of COVID-19, VirTrial was thoughtfully positioned to support the continuity of clinical trial conduct throughout the pandemic. In her position, Amanda became a sought after DCT subject matter expert and speaker across the globe. VirTrial was ultimately acquired by Signant Health in 2020.

Prior to VirTrial, Amanda led the US-based global sales team for Synexus, the largest site network in the world with 200 sites across 11 countries. With centralized administrative processes and standardized business functions, the unique efficiencies of Synexus set it apart from other clinical research sites and ultimately led to its acquisition by PPD in 2015.

For the last decade, Amanda has been an active contributing member for the Society of Clinical Research Sites (SCRS), whose mission is to unify the voice of the global clinical research site community for site sustainability.

Amanda earned a Bachelor’s degree in Kinesiology from Arizona State University and a Master’s degree in Integrative Physiology from the University of Colorado at Boulder.

Megan Robertson, MBBS, FRACP, FANZCA, FCICM
Group Chief Research Officer, Director of Research 
St. Vincent’s Hospital Melbourne, Australia 

Megan Robertson is an alumna of the University of Melbourne where she completed a Bachelor of Medicine, Bachelor of Surgery (MBBS). She is the current Group Chief Research Officer at St Vincent’s Health Australia and Director of Research at St Vincent’s Hospital, Melbourne.  She also works as a Senior Intensive Care Consultant at Epworth HealthCare (Richmond and Freemasons). She is on the boards of the Digital Health CRC, Opyl AI, St Vincent’s Institute of Medical Research, FearLess (PTSD-ANZ), and Queen’s College (Univ of Melbourne), and the Tuckwell Scholarship Selection Panel at ANU. She also works with national bodies including the Australian Commission on Safety and Quality in Healthcare, AusBiotech, and the National Health and Medical Research Council. Previously, she held positions as the Director of Professional Affairs, CICM, as the Executive Director of Research at Epworth HealthCare, and as the Co-Director of the Intensive Care Unit at Epworth Freemasons.​

Neil Smith, BSc (Hons)
Director Clinical Operations APAC
ObvioHealth, Australia

Neil Smith is the Director of Clinical Operations for ObvioHealth based in Melbourne, Australia and is responsible for the oversight of Obvio’s regional APAC studies.

Neil is a Clinical research professional with 25 years of experience in the pharmaceutical industry, having worked in Pharmaceutical and CRO companies in Australia, the United Kingdom and South Africa. Neil has worked in a broad range of roles and responsibilities, having worked in leadership teams, and as a Line Manager, Project Manager, Independent Consultant and CRA.

His first monitoring role in the industry was to bring “Telfast” to the world. Later in his career worked on more complex clinical trials in HIV in South Africa, and predominantly Oncology and Hematology studies in Australia.
He has led and supported a number of global clinical trials from startup to close out in the General medicine group of large pharma. He has managed all phases of clinical trials.
Neil lives with his wife, 3 children, 3 dogs, mini lop eared rabbits and marine fish. He loves his Judo and has been practicing this for over 20 years, being actively involved in coaching, tournament organization, and competition. He loves tinkering with technology like building crypto miners and is a mad Springbok rugby fan.

Carolyn Stewart, MMSc
Business and Operations Manager
Melbourne Children’s Trials Centre, Australia

Carolyn Stewart is the Business and Operations Manager of the Melbourne Children’s Trials Centre (MCTC) which is a collaboration between The Royal Children’s Hospital, Murdoch Children’s Research Institute, and the University of Melbourne. MCTC supports all types of clinical research ranging from trials of novel therapeutic agents to large public health prevention trials and aims for excellence in the design and conduct of clinical trials and leadership in paediatric health research. Carolyn has a master’s degree in Medical Sciences (Drug Development) from the University of New South Wales and has more than 35 years’ trials experience within both the healthcare and the pharmaceutical industries. She has worked in various clinical and operational management roles and has experience in all phases of clinical trials in a broad range of therapeutic areas.

Adam Stoneley 
Research Operation Manager
Icon Group, Australia

Adam Stoneley is the Senior Operations Manager responsible for Research Innovation and Governance at Icon Group. Adam is a firm advocate of Icon Group’s simple vision to deliver the best care possible to as many people as possible, as close to home as possible. Icon Group is Australia’s largest dedicated private provider of cancer care and brings together medical oncology, haematology, radiation oncology, chemotherapy compounding and pharmacy to deliver a true end-to-end offering. Prior to working with Icon, Adam worked in various roles for Queensland Health, Princess Alexandra Hospital and Cancer Council Queensland in roles ranging from clinical trial coordinator and clinical coder to epidemiological survey programmer and network administrator. Adam’s interests and the remit of his current teams include the incorporation of novel technologies, policies and collaborations to deliver the best care possible to as many people as possible, as close to home as possible.

Courtney Valeo
Director, Consultative Services
Greenphire, USA

Courtney Valeo is the Director, Consultative Services at Greenphire, the leading provider of global financial lifecycle management solutions for clinical trials. She has spent over 10 years supporting Clinical Trial sponsors and sites utilizing Greenphire’s platforms. Courtney is responsible for providing best practice recommendations for both study-specific and portfolio-wide implementations and leads a team of business consultants who work collaboratively across the stakeholders to identify opportunities for product and process improvements.

David Vulcano, LCSW, MBA, CIP, RAC
Honorary President
SCRS, USA

David Vulcano. Vulcano brings nearly 30 years of experience within the clinical research industry and has been a member of the SCRS Leadership Council since 2015, providing guidance and direction for the company’s initiatives as a strong advocate for clinical research sites.

In addition to his new role with SCRS, Vulcano is chair of the SCRS Public Policy Committee and co-chair of SCRS’ Site Payment Initiative. He is a mentor to sites in the SCRS online site member community and frequent speaker at SCRS Site Solutions Summits, webinars, and Sites NOW meetings. Vulcano was selected as the recipient of the inaugural SCRS Christine K. Pierre Site Impact Award in 2019. Currently, Vulcano works with HCA Healthcare, where he has been Vice President of Research Compliance and Integrity for 14 years.

Catherine Wilson
Site Alliance Manager 
Parexel, Australia

Catherine has over 10 years’ experience in clinical research, including 3 years clinical monitoring; 4 years auditing and 3 years as a Clinical Trial Coordinator. This includes: Clinical monitoring activities included initiation, routine monitoring and close-out visit activities for a variety of Phase II-IV studies; Site auditing included performing contracted Phase I – IV Investigator Site Audits; internal compliance; vendor selection and requalification activities; TMF audits; and hosting and facilitating Sponsor Audits.

Prior to transitioning to CRO, she was the primary Clinical Trial Coordinator within the Urology Department at the Royal Adelaide Hospital where she was responsible for managing and executing all aspects of clinical trial research in accordance with ICH-GCP guidelines and applicable local regulations.

Elizabeth Wilson, BPharm, Post Grad Dip Clin Pharm
Director of Prime and Partner Sites ANZ
IQVIA, ANZ

Proactive and strategic senior leader with over 28 years’ experience in clinical research, including six years in the academic arena and eight years in commercial biotechnology companies. Most recently focused on strategic site relationships, set-up and maintenance of advisory boards and Early Phase Development of novel agents for cancer. Customer focus and relationship management is a major strength. Clinical Project Management and Clinical Operations Management and Development since 2002 from first in man, phase I through to global phase III international and local studies. Significant experience in oncology & haematology therapeutic areas. In addition, project manager for clinical program phase I to III of a first in class treatment for solid tumours. Extensive experience in diagnostic imaging with phase I and II trials of an imaging agent for diagnosis and subsequent treatment of deep vein thrombosis and pulmonary embolism. 13 years’ experience with Clinical Research Organization (CRO) both line management and strategic site relationship management roles.

Personal mantra is the assurance that all decisions have the patient as the central driver.

Simon Windsor
Manager Research Governance and Ethnics
Southern Adelaide Local Health Network, Australia

Anne-Marie Woods, RN
CCTC Manager
Austin Cancer Clinical Trials (CCTC), Australia

Anne-Marie has over 20yrs clinical research experience within the public health sector. She is the manager of Cancer Clinical Trials (CCTC) at Austin Health in Melbourne. Austin CCTC has expertise in conducting First-in-human Phase 1 to Phase 3 Oncology and Haematology clinical trials managing a portfolio of over 200 trials. Anne-Marie is passionate about promoting excellence, quality and efficiency in research practices through collaboration, innovation and engaged leadership. Prior to her manager role she was the CCT Quality Lead, which at that time was a unique and highly successful clinical site position offering support across the department, enhancing quality in all areas of clinical trial management operations.

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