Clinical Trials Project Manager – Medical Devices

The Effective People Group; Melbourne; Hybrid; AUD 110,000 - 150,000; Full time

Job summary

The Effective People Group is seeking a Clinical Trials Project Manager to lead and deliver medical device trials across Australia and New Zealand from Melbourne. You will coordinate study start-up, site qualification, ethics submissions and monitoring, working with international clients, physicians and site teams.

The role offers autonomy, strong stakeholder engagement and a commercially aware approach. Hybrid working options are available, and the remuneration is negotiable based on

Qualifications

• Experience running or managing clinical trials in medical devices.
• Excellent organisational and time management skills.
• Strong communication and stakeholder management capability.
• Ability to manage multiple priorities with a high degree of autonomy.

Responsibilities

• Managing and coordinating clinical trials from study start-up through to close-out
• Coordinating site qualification, initiation and close-out activities
• Managing ethics and governance submissions
• Interpreting study protocols and contributing to study planning
• Preparing and reviewing essential clinical trial documentation
• Coordinating study materials and ongoing site requirements
• Monitoring study progress and proactively addressing issues and risks
• Supporting protocol amendments and adverse event management
• Managing queries relating to protocols, ethics and study documentation
• Developing and maintaining strong relationships with physicians and clinical sites
• Working collaboratively with monitors and Field Technical Support
• Contributing to study budgets, quotations and commercial considerations
• Maintaining accurate project administration and reporting

Skills

Clinical trial management

Medical devices trials

Stakeholder management

MS Office

Communication

Project coordination

Time management

Autonomy

Tools

MS Office Suite

Job description

Clinical Trials Project Manager – Medical Devices

Remuneration: Negotiable based on experience

Our client a local CRO specialising in Medical Device trials throughout Australia and New Zealand are seeking an experienced Clinical Trials Project Manager to join their team and take ownership of this key role within the business.

Working with international clients across Cardiology, Cardiovascular,Vascular and Respiratory, this role will suit an experienced clinical trials professional who enjoys bringing together clinical expertise, project management, stakeholder engagement and commercial awareness to deliver successful clinical trials.

About the role

As Clinical Trial Project Manager, you will coordinate and deliver clinical trials across the study lifecycle, working closely with international clients, physicians, clinical sites, monitors and technical support teams.

You will have genuine responsibility for assigned studies, with the autonomy to manage priorities, anticipate challenges and drive projects forward in a dynamic clinical environment.

Key responsibilities include:

• Managing and coordinating clinical trials from study start-up through to close-out
• Coordinating site qualification, initiation and close-out activities
• Managing ethics and governance submissions
• Interpreting study protocols and contributing to study planning
• Preparing and reviewing essential clinical trial documentation
• Coordinating study materials and ongoing site requirements
• Monitoring study progress and proactively addressing issues and risks
• Supporting protocol amendments and adverse event management
• Managing queries relating to protocols, ethics and study documentation
• Developing and maintaining strong relationships with physicians and clinical sites
• Working collaboratively with monitors and Field Technical Support
• Contributing to study budgets, quotations and commercial considerations
• Maintaining accurate project administration and reporting

About you:

You will ideally have previous experience running or managing clinical trials in medical devices, together with a strong clinical background in one or more of the following areas:

• Cardiology
• Cardiovascular
• Vascular
• Respiratory

You will also bring:

• Strong clinical trial project management experience
• Experience working in medical device trials
• Excellent organisational and time management skills
• The ability to manage multiple priorities with a high degree of autonomy
• Strong communication and stakeholder management capability
• Strong working knowledge of MS Office Suite
• Experience working with clinical sites and healthcare professionals (including physicians)
• A strategic, commercially aware and solutions-focused approach
• The ability to navigate the operational and commercial considerations of a clinical environment
• A genuine interest in expanding your expertise across new clinical areas and medical technologies
• A professional, accountable and collaborative approach
• Be able to offer and assist clients clinical support throughout projects.

The role is primarily based in Melbourne, with regular attendance at client and clinical trial sites. This is an exciting time to join this collaborative team who are passionate about providing support to develop exceptional solutions for patient care.

A competitive salary and hybrid working options are available for the right candidate.