Melanie Gentgall
Moffat Beach,Australia
Summary
- HEAD OF CLINICAL OPERATIONS
- CHAIR, FACULTY OF CLINICAL RESEARCH NURSES, ACN
- DIRECTOR
- CEO
- COMPANY SECRETARY
- BUSINESS START UP AND DEVELOPMENT SPECIALIST
- CORPORATE AND CLINICAL GOVERNANCE
- EXTENSIVE HEALTH INDUSTRY EXPERIENCE
- CHANGE MANAGER
- ADVANCED PROJECT MANAGEMENT EXPERTISE
- EDUCATION DESIGN AND DELIVERY
- NATIONALLY RECOGNISED CLINICAL TRIALS THOUGHT LEADER
- RESEARCH ETHICS COMMITTEE MEMBER
- INVITED SPEAKER
- BUSINESS MARKETING AND DEVELOPMENT
- REGISTERED NURSE
- INDUSTRY MENTOR
- NATIONAL ADVISORY COMMITTEE MEMBER
Overview
28
28
years of professional experience
Work History
Head of Clinical Operations
Sanofi Translational Science Hub
08.2023 - 09.2024
- Inaugural Head of Clinical Operations for this new venture whose mission is to accelerate MRNA vaccine technology, quality and safety
- Established networks and operating models, employ and manage staff, established the corporate strategy and strategic plan and oversees clinical trial activities in Australia and in other regions.
Deputy Director Clinical Trials
University of the Sunshine Coast
09.2022 - 08.2023
- Alongside the Director, manage clinical trials staff of over 65 and assist in BD and strategic planning activities
- Responsible for stakeholder management and new relationship building and partnership opportunities
- Driving systems innovation and improved operations, to support future growth.
Director, Clinical Trial Platform
South Australian Health and Medical Research Institute
09.2021 - 10.2022
- Analysis of current operating models and planning for future business models and opportunities across local strategic partners, including University and Health settings
- Unit restructure and implementation of quality management systems
- Staff management and oversight, and management and involvement in grant writing and grant project support activities including budget and trial design advice and resourcing requirements.
CEO and Company Secretary
PRAXIS Australia Limited
12.2014 - 10.2021
- PRAXIS Australia is an NFP and registered charity that brings together Sydney University, Global Reconciliation (another NGO, affiliated with Monash University) and Bellberry Ltd
- Appointed as the founding CEO of PRAXIS and responsible for all aspects of the business design, strategy, management, and development of the Company since its genesis.
Education Project Manager
Bellberry Ltd, Human Research Ethics Committee
02.2014 - 12.2014
- Established, developed and implemented a VET accredited training package in Human Research Ethics and Research, tailored for external growth and expansion nationally
- Development of a business plan to guide and support the implementation of the education package.
Clinical Research Manager
University of Adelaide
10.2006 - 02.2014
- Co-establishment of a newly formed, specialised clinical research business unit (early phase trials unit) of the University of Adelaide
- Key responsibilities included management of all aspects of business and clinical operations for this complex early phase clinical research facility.
Project Manager
CMAX
09.2005 - 10.2006
- Managed a suite of early phase clinical research projects across a broad spectrum of disease indications
- Led a team of six clinical staff, with responsibility for all clinical and human resources functions.
Study Coordinator
The Queen Elizabeth Hospital, Dialysis and Transplantation Unit
01.1997 - 09.2005
- Functional responsibilities encompassed project coordination, patient recruitment, patient management, resource management, contractor liaison, facility management and staff education.
Education
Company Directors Course - Company Director/Executive
AICD
Adelaide, SA2021
Certificate IV - TAE
DrWed VET
Melbourne, VIC2016
Graduate Certificate - Renal Nursing Care
Queen Elizabeth Hospital
Adelaide, SA1993
Bachelor Of Health Sciences - Nursing
University of South Australia
Adelaide, SA11.1990
Skills
- Clinical Quality Improvement
- Patient relationship management
- Clinical supervision
- Effective communication
- Training and mentoring
- Project oversight
- Team Building
- Staff Management
- Hiring and recruitment
- Accreditation coordination
- Relationship building and retention
- Profit improvements
- Nurse education program development
- Unit-based shared governance
- Strategic planning
- Project estimation and bidding
Affiliations
- Member - Australian Nursing Federation
- Member – Australian College of Nursing
- ACRP – Previous State Chapter Representative, guest lecturer and exam supervisor
- Clinical Trial Magnifier (Journal) – Advisory Board Member (2008-2010)
Posterpresentations
- A study of Aranesp administered once monthly in anaemic chronic kidney disease patients, Disney, APS, Gentgall MG, Mander Bannon E, Viswilingam A, MacMillan J, EDTA, Lisbon, Portugal, 05/2004
- Investigation of the Effects of Pregabalin and the Glial Inhibitor Minocycline on Flare, Hyperalgesia, Allodynia and Pain Before and After I.D. Capsaicin in Patients with Unilateral Sciatica, Sardelis NM, Hutchinson MR, Gentgall M Rolan PE, Australian Pain Society Meeting, Gold Coast, Australia, 2009
- The PD and PK Of Single Dose R-Warfarin And S Warfarin When Administered Alone and In Combination as A Function Of VKORC1 Genotype In Healthy Volunteers, Maddison J, Somogyi A, Gentgall M, Jensen B & Rolan PE, ASCEPT, 2009
Skillsqualificationsexperience
- Chair, Faculty of Clinical Research Nurses (2021-2023)
- Co-author - professional practice standards for Australian Clinical Research Nurses (2020)
- Australian Institute of Company Directors Course (2021)
- Australian Consumer Health Forum – Special Interest Group Member (2020 – 2022)
- Australian Clinical Trials Alliance (ACTA) – Reference Group Member (2019-2022)
- CT:IQ: Advisory Committee Member
- Advisory Committee Member; Australian Clinical Trials Action Group – AusBiotech
- ATSE/IMNIS/MTPConnect Industry Mentor
- Australian Institute for Aboriginal and Torres Strait Islander studies (AIATSIS) – Ethics Committee Review Member (2014-2021)
- Bellberry Ethics Committee – Committee member, Scientific Reviewer (2010-2014)
- HoMER (harmonization of ethical research): NHMRC National Working Party member (2008)
- NHMRC: National Working Party, Education Model, Research Governance Practice
- NHMRC: National Working party – Development of the National Ethics Application form (NEAF)
- Graduate Diploma of Applied Sc. (Nursing) SACAE, Underdale Campus (1990)
- Grad Cert - Renal Nursing Care, TQEH (1993)
- Cert IV Training and Assessment (TAE) (2014)
- CCRC certified (International accreditation) ACRP (03/01/06)
- ICH/GCP for Professionals – certification ACRP (09/01/06)
- US Defense and Human Rights Protection Office ICH.GCP certification (2012)
Publications
- Randomised Crossover comparison of Intravenous and Subcutaneous Darbepoietin dosing efficiency in haemodialysis patients, Cervelli MJ, Gray N, McDonald S, Gentgall MG, Disney, APS, Nephrology, 2005
- Utility of saccadic eye movement analysis as an objective biomarker to detect the sedative interaction between opioids and sleep deprivation in opioid-naive and opioid-tolerant populations, Grace PM, Stanford T, Gentgall M, Rolan PE, Journal of Psychopharmacology, 11/2010
- Intradermal capsaicin as a neuropathic pain model in patients with unilateral sciatica, Verna Aykanat, Melanie Gentgall, Nancy Briggs, Desmond Williams, Sharon Yap, Paul Rolan, British Journal of Clinical Pharmacology, 07/2011
- The pharmacokinetics and pharmacodynamics of single dose (R)- and (S)-warfarin administered separately and together: relationship to VKORC1 genotype, J Maddison, A Somogyi, B Jensen, H James, M Gentgall, P Rolan, British Journal of Clinical Pharmacology, 05/2012
- Comparison of pain models to detect opioid-induced hyperalgesia, Sumithra Krishnan, Amy Salter, Thomas Sullivan, Melanie Gentgall, Jason White, Paul Rolan, Journal of Pain Research, 01/2012
- The Effects of Pregabalin and the Glial Attenuator Minocycline on the Response to Intradermal Capsaicin in Patients with Unilateral Sciatica, Nicole M. Sumracki, Mark R. Hutchinson, Melanie Gentgall, Nancy Briggs, Paul Rolan, PLOS one, 06/07/2012
- Increased Responsiveness of Peripheral Blood Mononuclear Cells to In Vitro TLR 2, 4 and 7 Ligand Stimulation in Chronic Pain Patients, Yuen Kwok, Mark R. Hutchinson, Melanie G. Gentgall, Paul E. Rolan, PLOS one, 08/28/2012
- Low-dose endotoxin potentiates capsaicin-induced pain in man: Evidence for a pain neuroimmune connection, Mark R. Hutchinson, Mara Buijs, Jonathan Tuke, Yuen Hei Kwok, Melanie Gentgall, Desmond Williams, Paul Rolan, Brain, Behavior, and Immunity, 05/2013
- Science at Warp Speed: Medical Research, Publication, and Translation During the COVID-19 Pandemic, Lipworth, W., Gentgall, M., Kerridge, I. et al., Bioethical Inquiry, 2020
- Who's included? The role of the Clinical Research Nurse in enabling research participation for under-represented and under-served groups, Beer K, Gentgall M, Templeton N, Whitehouse C, Straiton N, J Res Nurs, 03/2022
- Clinical Research Nurse (CRN): Australian Standards for Practice, Australian College of Nurses, 2022
Timeline
Head of Clinical Operations
Sanofi Translational Science Hub
08.2023 - 09.2024
Deputy Director Clinical Trials
University of the Sunshine Coast
09.2022 - 08.2023
Director, Clinical Trial Platform
South Australian Health and Medical Research Institute
09.2021 - 10.2022
CEO and Company Secretary
PRAXIS Australia Limited
12.2014 - 10.2021
Education Project Manager
Bellberry Ltd, Human Research Ethics Committee
02.2014 - 12.2014
Clinical Research Manager
University of Adelaide
10.2006 - 02.2014
Project Manager
CMAX
09.2005 - 10.2006
Study Coordinator
The Queen Elizabeth Hospital, Dialysis and Transplantation Unit
01.1997 - 09.2005
Company Directors Course - Company Director/Executive
AICD
Certificate IV - TAE
DrWed VET
Graduate Certificate - Renal Nursing Care
Queen Elizabeth Hospital
Bachelor Of Health Sciences - Nursing
University of South Australia