Job Title: Consultant, Senior Clinical Trial Manager, Medical Device – Australia (Sydney/Melbourne)

Salary or Pay rate: Open for right fit

Note: Only resume will be considered who has Medical device experience.

Expected Commitment

- This role will be an average of 20 hours per week with a varying schedule based on trial needs. The expected commitment is 1+ years. There are 7 sites in the study in the Sydney and Melbourne. Travel will be required.

Client Overview

Peritia, a Career Portfolio Management company servicing the drug, device, and biologic development community, is supporting a client with a need for a Clinical Trial Manager (CTM) with type 2 diabetes. Endoscopic, and/or medical device expertise. Our client has an innovation that leverages energy delivery in the small intestine (duodenum) to reset the body’s metabolic signaling system, harnessing its’ natural regeneration capabilities to restore metabolic function.

Client Business Driver

Our client is a start-up, private, medical device company pioneering type 2 diabetes control through the development of a novel application of a pulsed electric field, our client is establishing a recent era in treatment options for people living with T2D and their ability to regain control of their blood glucose levels.

The Work

The Clinical Trial Manager will lead and provide monitoring for the Australia-based type 2 diabetes device trial. This role will support 7 sites in the Sydney/Melbourne area. The primary objective is to oversee site management and compliance to ensure timely, high-quality results in support of regulatory goals.

Key Responsibilities





Oversee training and performance of clinical monitors and clinical sites (hospitals, research centers).

- Oversee the conduct of the clinical trial by visiting study sites to ensure the trial is being executed in compliance with the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Ensure all studies are conducted in accordance with FDA, EU MDR, ISO 14155, and Good Clinical Practice (GCP) guidelines.
- Collaborate on clinical trial management system set-up, monitoring metrics, and timely data cleaning and review.
- Track trial metrics, manage risk, and report on trial progress to internal stakeholders and regulatory bodies.

Qualifications

- Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field.
- Minimum of 10 years in clinical trial management and/or monitoring within the medical device industry.
- Proven track record in managing end-to-end clinical trial processes, including study design, site management, monitoring, and close-out.
- In-depth understanding of FDA and AUS regulations, ICH-GCP guidelines, and ISO standards pertinent to clinical trials.
- Familiarity with regulatory submissions (e.g., IDE, PMA) and interactions with regulatory bodies.
- Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) tools.
- Ability to analyze and interpret clinical data, ensuring data integrity and compliance.
- Strong leadership and team management capabilities.
- Preferred Skills: Advanced degree in Life Sciences
- Experience with diabetes and/or endoscopic trials

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📌 Clinical Trial Manager (Melbourne)
🏢 Important Company of the Sector
📍 Melbourne