Clinical Trial Liaison - Part Time (0.5 FTE) Australia
- Experience Level
- Experienced (non-manager)
Clinical Trial Liaison
Rare Disease/ Nephrology
Business Unit: Clinical Operations – outsourced through Amplity Health
Location: Work from home – Australia
Part time: 0.5 FTE
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.
- 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
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
These are our company values that we expect all candidates and potential employees to embody as these values strongly underpin our culture:
Amplity Health is an equal opportunities employer - if you require any questions about your application please contact Recruiter
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