Clinical Trial Liaison (CTL) - (Oncology) - Australia

Clinical Trial Liaison (CTL)

Business Unit: Clinical Development & Operations
Reports to: Field Manager, Amplity Health / Regional Lead CTL
Location(s): Australia
Territory: Australia
Individual or Manager: Individual

Purpose of Role

The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the local fieldbased
representative for the sponsor company in one or more countries/regions supporting clinical
development programs. The CTL interacts with investigator sites and other parties related to clinical trial
execution.

The CTL provides regional and country specific insights to support study feasibility, site identification and
selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both
identifies and helps facilitate resolution of investigator site issues.

Key accountabilities:

Provides country/regional operational insight into site feasibility and selection and overall
patient recruitment strategy
Participates in Clinical Study Team Meetings and Quality Review Meetings where necessary
providing input to study teams on operational issues based on site visits and contacts
Attend and present at investigator meetings, monitor workshops
Participate in site visits with investigators site staff and CRO representatives in support of
clinical trial execution and report back to study teams e.g. feasibility, start-up activities,
enrolment or escalated site issues
Responsible for review, documentation and follow up of investigator site issues including
tracking metrics
Provides sponsor regional operational support and acts as point of escalation for investigator
sites
Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor
representative
Contributes to process improvement initiatives when required
Perform oversight monitoring on a triggered basis, as required, and produce relevant reporting
and feedback
Ensure compliance with SOPs (Standard Operating Procedures), GCP (Good Clinical
Practice) and other relevant guidelines/processes on an ongoing basis
Act as field-based reference point of scientific and clinical expertise for study sites.

Essential Skills, Knowledge and Experience

Education:

Pharmacist, PhD, MSc in a relevant scientific field or associated qualification (preferred), BSc. min.
requirement
Fluent written and spoken English (mandatory) and local language of country to be covered

Experience:

Minimum 5 years relevant experience in pharmaceutical industry
MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience e.g. CRA
(Clinical Research Associate) preferred, KAM (Key Account Manager) with Clinical Trial background
possible
Clinical trials experience and understanding of clinical trial methodology and management
Experience of working within relevant therapeutic area
Experience in management of KOLs, Researchers and HCPs at all levels in both 1:1 and group settings
Experience of working within the relevant National Pharmaceutical Codes of practice.

Skills:

Communication and strong, collaborative interpersonal skills
Demonstrable thirst for knowledge (technical, clinical, medical, scientific) with an ability to
assimilate information quickly, present clinical data clearly and concisely and discuss the
statistical and clinical relevance in line with clinical development strategy
Ability to work autonomously, in a field-based setting, whilst contributing positively to the Clinical
Operations Function
Ability to drive performance of self and others

Highest ethical, transparent standards

Job Requirements:

• Extensive experience in global clinical trial operations required
• Experience in Oncology trials a role requirement
• High travel required – International responsibility may be required, flexibility needed
• Extensive medical and scientific knowledge and clinical development understanding
• Excellent communicator of technical and scientific information
• Excellent interpersonal skills, ability in both in-person and virtual engagement of HCP’s
• Demonstrated collaborative as well as independent working style
• Ability to build relations with the external medical community
• Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs)
• Strong organizational skills with effective use of time and prioritization. Must be able to prioritize and
manage a high volume of studies – Pharmaceutical company have a very large cross-therapeutic
portfolio of clinical trials being run globally
• Cross cultural awareness and fluent in at least one commonly spoken European language in addition to
English
• A working knowledge of ICH/GCP

TEAM MEMBERSHIP AND KEY INTERFACES:

List key team memberships and cross-functional interfaces essential for success in this role

Key Team Membership:

• Clinical Study Team Meeting(s)
• Clinical Operations Review Meeting(s)
• Clinical Compliance and Quality Meeting(s)

Cross Functional Interfaces

• Clinical Project Management and Operations
• Medical Affairs
• Regulatory Affairs
• Medical Director(s)

About Amplity

Amplity Health is the true partner of global healthcare companies who builds transformational solutions by
challenging the boundaries of commercialization strategies to improve the lives of patients.

We do this through:

Commercialization – Amplity Health has the expertise, people and infrastructure to meet a wide range
of commercialization challenges
Clinical & Medical Outsourced Solutions – Building end to end external engagement solutions and
capabilities across clinical and medical affairs globally
Consulting – Building end to end external engagement solutions and capabilities across clinical and
medical affairs globally
Remote Engagement – Alternative channels across the medical and commercial continuum to engage
with HCPs and patients
Field Outsourced Solutions – Tailored field team programs to meet a wide range of objectives and
client needs

Values

These are our company values that we expect all candidates and potential employees to embody as these
values strongly underpin our culture:
Excellence
Passion
Integrity
Innovation
Collaboration

Amplity Health is an equal opportunities employer. Amplity Health believes that drawing upon the talents of people from diverse backgrounds and experiences enriches our performance. We seek to create an inclusive, fair, and respectful environment that celebrates individual differences and the unique perspectives they bring. Diversity at Amplity Health includes ethnicity, gender, age, religion, disability, national origin, and sexual orientation. It also encompasses recognizing the uniqueness of everyone’s characteristics, styles, and experiences. At Amplity Health, we believe our people are the foundation of our success.

Please note: If you have not received a response to your application within 4 weeks, you have not been successful on this occasion.  Please register on our portal for other opportunities