Skip to main content

This job has expired

International Clinical Trial Liaison - Part Time (0.5 FTE) Australia - Rare Disease / Nephrology

Employer
Amplity Health
Location
Australia
Salary
Above industry average base salary plus annual bonus and car allowance
Start date
20 Sep 2021
Closing date
20 Oct 2021

Job Details

Clinical Trial Liaison

Rare Disease/ Nephrology

Australia

 

Business Unit: Clinical Operations – outsourced through Amplity Health

Location: Work from home – Australia

Part time: 0.5 FTE

Travel: 60-70%

Territory: Australia and New Zealand

 

Purpose of Role

We have an opportunity for you to support an exciting biopharmaceutical company and its ongoing and future clinical trials as a Clinical Trial Liaison (CTL) in rare disease/ nephrology space.

The CTL will represent the sponsor and will work with the clinical investigators and site staff to provide education, support enrolment and retention initiatives.

Focus of this role would be oversight of the CRAs engaged by the CRO, participation in site engagement activities; ensuring compliance with applicable guidelines/SOPs (Standard Operating Procedures), GCP (Good Clinical Practice) and other relevant guidelines/processes on an ongoing basis; ensuring inspection/audit readiness.

The role will work very closely with the client’s internal study staff, CRAs from the CRO as well as the CTL Teams in the US and Europe. Reporting into the US Sr Director Clinical Compliance.

Responsibilities

  • To build and promote on the image and professionalism of the Client in the assigned region
  • Support of ongoing and future company sponsored trials for all company’s pipeline products
  • Act as field-based reference point of scientific and clinical expertise for study sites
  • Develop strong relationship with PI and site staff
  • Ensure that the CRO is conducting monitoring visits in a quality manner in compliance with applicable Sponsor and CRO plans, and ICH/GCP Guidelines.
  • Responsible for monitoring oversight: ensure data quality/provide monitoring trends, issues, and lessons learned
  • Liaise closely with the relevant study teams and monitor study performance
  • Provide expert guidance, tools and informational support to CRO staff, MSLs, Patient advocacy
  • Liaison between clinical operations and study sites e.g. visit trial centres as required to provide updates on study compound and maintain company presence and enhance enrolment and retention rate
  • support during COVID-19 times: ensuring patient visits takes place, IP is delivered to the patient, study procedures are done remotely and via Global Home Care service
  • support in data cleaning for clinical studies: close collaboration with the CRAs and sites to resolve queries, improve data entry and SDV%
  • Support Client’s presence in selected local and international congresses in alignment with the Client’s clinical development strategy (e.g. staffing of clinical development/non-promotional booths at medical congresses) – as required
  • Support relevant education at Site Investigator Meetings (SIMs) in line with clinical study plans (as requested).

Skills / Knowledge / Experience needed:

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience working within Nephrology or Rare Disease
  • Ability to manage a geographically assigned territory from a home-based office.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Knowledge of overseeing study sites in your territory, incl. management of CRA’s including optimization of enrolment strategies
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail
  • Able to use initiative and problem solve
  • Flexible and adaptive approach to work.  Able to work in a team and as an individual.
  • Ability to identify issues and resolve appropriately with guidance
  • Be available for extensive travel including overnight stays, as required
  • Valid driver's license
     

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 - if you require any questions about your application please contact Recruiter

Company

Amplity Health is a contract medical and commercial organization that is the True Partner of Global Healthcare Companies. We continually challenges the boundaries of medical and commercial strategies to accelerate the approval and launch of new drugs to improve the lives of patients. With experts on six continents in over 30 countries, Amplity has the expertise, global infrastructure, and data-driven insights to help clients overcome their medical and commercial challenges.

We are proud of our inclusive culture and our EPIIC values, which are reinforced in our people, our processes, and the solutions we provide for our clients:

Values 2

 

 

Hear more about our EPIIC values from our Chief of Staff:

EPIIC Values Video-450

 

 

Hear from our VP, Medical Solutions about why you might want to consider a career with us:

Why consider Amplity-450

 

Company info
Website
Telephone
01753251321
Location
Amplity House
The Vale
Chalfont St Peter
Buckinghamshire
SL9 9RZ
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert