Gina Paine
Burleigh Waters
Summary
Dedicated clinical research professional with over 10 years of experience in the clinical trials landscape, now expanding into business development and commercial services. Known for a collaborative leadership style that builds cohesive relationships across internal teams and external stakeholders. Skilled in cultivating strong client partnerships and delivering tailored solutions that meet evolving needs. Brings proven project management expertise combined with a solid understanding of the biotech sector, aiming to leverage these strengths to foster business growth at Novotech.
Overview
13
13
years of professional experience
Work History
Project Manager
Novotech
04.2025 - Current
- Manage phase IIb studies in idiopathic pulmonary fibrosis and complement-mediated renal disease, overseeing project timelines, budgets, and deliverables.
- Collaborate with cross-functional teams to identify and nurture business opportunities, ensuring alignment with client objectives.
Senior Clinical Research Associate (Lead CRA)
LCRA
03.2021 - Current
- Acted as the main contact for clients during critical phases of trial execution, addressing inquiries and strategizing solutions to enhance study outcomes.
- Assisted in the development of study proposals and presentations, ensuring they were tailored to effectively address client needs and expectations.
Senior Clinical Research Associate (Lead CRA)
LCRA
03.2021 - Current
- Taking full responsibility for project during PM leave – weekly client calls, supporting change order, vendor management.
- Successfully navigated first patient randomisation
- Completing Month end financials
- Helped sponsor to strategize protocol amendment submissions.
- Review and provide feedback on key study documents – Protocol, PICFs, Manual of procedures, updating study plans.
- Keeping CRA team engaged by identifying site priorities, identifying areas for process improvement, and maintaining positive and encouraging relationships.
- Development of operational tools, training materials and monitoring tools.
- Driving changes to vendor agreements and managing vendor relationship.
- Familiarity with study start-up processes and language translation requirements in Hong Kong and Singapore
Senior Clinical Research Associate (Acting as PM)
George Clinical
08.2018 - 03.2021
- Managed financial activities and communication between clients and internal teams, ensuring all project elements were delivered on time and within budget.
- Participated in client meetings to communicate study progress and troubleshoot challenges, fostering strong relationships and trust.
Senior Clinical Research Associate – with Project Management responsibilities
George Clinical
08.2018 - 03.2021
- Act as first point of contact for the client reporting directly to the Project Director.
- Responsible for completing month end activities.
- Managed COVID related change order to incorporate remote monitoring visits and extended study timelines.
- Provide timely site status updates direct to client as required.
- Drive study start-up activities.
- Facilitate site feasibility outreach and completion of SSVs.
- Execution of lead ethics submissions for Australian and New Zealand
- Coordinated regulatory submissions.
- Manage site budget negotiation, prepare and finalise contracts within fair market value.
- Identified the need for site contract amendments. Negotiate site proposed changes between client and site to arrive at a resolution.
- Develop local language materials including Informed Consent forms
- Knowledge sharing with peers and provision of ongoing training and mentorship to junior team members, as well as keeping watch over CTA’s during line manager’s leave and scheduling meetings to oversee appropriate resourcing.
Clinical Research Associate II
Novotech
07.2015 - 04.2017
- Conducted various study start-up activities and facilitated client interactions at project milestones, leading to improved client satisfaction and retention.
- Provided insights into study processes and recommendations for operational efficiencies based on feedback gathered during site visits.
Clinical Research Associate
Novotech
11.2014 - 04.2017
- Performed study start-up activities across all study phases (I-IV) including observational studies, and across various therapeutic areas.
- Negotiated site contracts and
- Carried out ongoing site management of complex clinical trials on behalf of global drug companies and across various therapeutic areas such as rheumatology, cardiology, dermatology and oncology.
- Monitored multiple high recruiting trial sites to ensure protocol adherence and compliance with regulatory, ethics and ICH-GCP requirements.
- Proficiently performed site monitoring for all visit types inclusive of SIVs, IMVs, COVs and unblinded MVs.
- Completion of clinical trial monitoring visit reports via CTMS.
- Worked closely with sites to meet database lock timelines and promote efficient trial management to completion.
- A vital part of my role was safeguarding the wellbeing of trial participants through the review of patient data, data integrity and reporting of all adverse events, SAE’s to the sponsor.
- Fostered a culture of knowledge sharing within the workplace amongst peers and provided personal advice and guidance to junior member of staff.
Clinical Trials Assistant
Novotech
01.2014 - 11.2014
- I started at Novotech as a Clinical Trials Assistant, responsible for providing efficient and reliable administrative and logistical support to the clinical project team across multiple small and large scale studies. As the lead CTA one the company’s largest projects at the time, I was able to identify process gaps and collaborated with senior department staff to develop and successfully implement a new streamlined process for alliance partner systems access, resulting in increased productivity. My passion for learning and ability to take on increased responsibility allowed me to progress quickly through the ranks to Clinical Research Associate.
Drug Safety Assistant
Novartis Pharmaceuticals Australia
06.2013 - 12.2013
- Execution of local activities relevant to the management of safety data, which included supporting the submission and distribution of SAE and SUSAR reports, follow up letters and relevant tracking.
- Monitor and manage receipt and triage of communication in dedicated Drug Safety mailbox
- Provided support for health authority inspections, audits and corrective action plans and ensure inspection preparedness by maintaining local documentation (including archiving/ tracking/ retrieval) and consistently applying archiving policies as per company SOPs.
- Performed administrative tasks to assist the team in relation to preparedness for FDA audit.
- Coordination of regular team meetings and team building activities
- Experience using drug safety database (Argus)
- During my time at Novartis, I showed a consistent commitment to providing quality administrative and logistical support to the Drug Safety and Epidemiology team and head of department. In this role I was responsible for acknowledging and submitting safety reports within regulatory timelines. As a result of performance I was also chosen to attend a pharmacovigilance webinar hosted by Novartis in conjunction with ARCS Australia, which provided me with vital insight into the industry.
Senior Pathology Clerk
Capital Pathology
12.2012 - 05.2013
Education
Bachelor - Biomedical Science
Bond University
Gold Coast, QLD01.2012
Juris Doctor - Law
Bond University
Gold Coast, QLD06-2026
Certificate - Project Management, The Complete Guide
Sydney University, Centre For Continuing Education
Sydney, NSW02.2019
Skills
- Client relationship management
- Analytical problem-solving skills
- Understanding of Clinical Trial Budgets and Contracts
- Good communication & interpersonal skills
- Project Management
- Motivating and influencing others
- Management of competing deadlines
- Familiarity with Salesforce and Financial Systems
- Thorough knowledge of ICH-GCP
Study Experience
- Company: Novotech, Australia
- Role: Project Manager Apr ’25 – present
- Study: Global, phase IIb idiopathic pulmonary fibrosis, Global, phase I/IIa complement mediated renal disease
- Role: Associate Project Manager Jun ’23 – Mar ’25
- Study: Global, phase IIb idiopathic pulmonary fibrosis, Global, phase I/IIa complement mediated renal disease, Regional, phase IIa refractory ascites due to liver cirrhosis, Local, GMO, prostate cancer
- Role: Senior Clinical Research Associate Mar ’21 – Sep ’22
- Study: Regional, phase Ib geographic atrophy, Regional, phase II geographic atrophy, Local, phase I advanced solid tumors
- Company: George Clinical, Australia
- Role: Senior Clinical Research Associate Aug ’18 – Feb ’21
- Study: Local, phase III device (pacemaker) bradycardia, Local, phase II multiple sclerosis, Local, phase III paediatric growth hormone deficiency, Local, phase III IgA nephropathy
- Role: Clinical Research Associate Apr ’17 – Aug ’18
- Study: Local, phase III diabetic nephropathy, Local, phase I advanced solid tumors
- Role: Clinical Research Associate II Jul ’15 – Apr ’17
- Study: Local, phase IV atrial fibrillation, Regional, phase III rosacea, Local, phase II chronic heart failure
- Role: Clinical Research Associate I Jan ’14 – Jun ’15
- Role: Clinical Trial Assistant Jan ’14 – Nov ’14
- Study: Global, phase III ESRD, Global, phase III epilepsy, Regional, phase II glioblastoma, Regional, phase II atopic dermatitis, Local, phase I multiple sclerosis, Global, phase III hearing loss
- Company: Novartis Pharmaceuticals, Australia
- Role: Drug Safety Assistant Jun ’13 – Dec ’13
- Company: Capital Pathology, Australia
- Role: Senior Pathology Clerk Dec ’12 – May ’13
Timeline
Project Manager
Novotech
04.2025 - Current
Senior Clinical Research Associate (Lead CRA)
LCRA
03.2021 - Current
Senior Clinical Research Associate (Lead CRA)
LCRA
03.2021 - Current
Senior Clinical Research Associate (Acting as PM)
George Clinical
08.2018 - 03.2021
Senior Clinical Research Associate – with Project Management responsibilities
George Clinical
08.2018 - 03.2021
Clinical Research Associate II
Novotech
07.2015 - 04.2017
Clinical Research Associate
Novotech
11.2014 - 04.2017
Clinical Trials Assistant
Novotech
01.2014 - 11.2014
Drug Safety Assistant
Novartis Pharmaceuticals Australia
06.2013 - 12.2013
Senior Pathology Clerk
Capital Pathology
12.2012 - 05.2013
Bachelor - Biomedical Science
Bond University
Juris Doctor - Law
Bond University
Certificate - Project Management, The Complete Guide
Sydney University, Centre For Continuing Education
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