Clinical Trials Manager

**Clinical Trials Manager**

OncoRes Medical was founded at the intersection of medicine, science and humanity to improve
the accuracy of breast-conserving surgery and eliminate the physical, psychological and economic
burdens associated with repeat operations.

Our unique, informal culture champions vision, restlessness, and humanity. Knowing we have an
open and supportive team means each of us has the freedom to take responsibility and
ownership. We have a shared passion to work restlessly, pioneering change to re-imagine the
world while remaining grounded in our commitment to science and quality.

Our passion for helping patients focuses us on the patient. We believe that all breast cancer
patients deserve the opportunity to move beyond their breast cancer surgery knowing that all the
cancer has been removed, the first time. In everything we do, we are thinking about how we can
inch closer to a world free from re-excisions... We are going BEYOND BREAST CANCER

**Overview**:
The Clinical Trials Manager at OncoRes Medical is responsible for managing the successful and
Program team and support ongoing research and development at OncoRes Medical.
If you want to use your expertise to help develop a novel, disruptive medical product that will
impact the lives of millions of people around the world, get in touch This is a unique opportunity
to get involved in an early, rapidly growing company with significant growth and development

**Responsibilities**:

- Lead all aspects of clinical trial start-up activities (_e.g._, ethics and governance approvals).
- Support the execution of the trials, working closely with the clinical team in OncoRes and

key external parties (_e.g._, principal and clinical investigators, research nurses, and Clinical
Research Organisations).
- Oversight of Trial Master File and Essential Documents.
- Proactively ensure the successful delivery of clinical trials as defined by the clinical

development team including:
o Management of timelines, budgets, and allocation of internal resources ensuring
project milestones and deliverables are monitored and achieved.
- Anticipating, identifying, and managing potential study risks, including
implementing contingency plans to ensure mínimal disruption throughout the study
program.
- Ensure studies are conducted in accordance with applicable guidelines (_e.g._, standard

operating procedures and local; national and international regulations)
- Develop trial-related training material and run training modules.
- Prepare reports reflecting study progression.
- Serve as liaison with participating clinical research sites.
- Contribute to technical analysis of results in relation to clinical outcomes.
- Understand ICH Good Clinical Practice and regulatory guidelines.
- Provide clinical trial support for formal regulator engagements.
- Develop and maintain strong working relationships with investigators and study staff
- Serve as an ambassador to promote OncoRes Medical’s core values; we are Inspired,

Restless, Human and Visionary.

**Qualifications**:

- Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology,

Chemistry, Biochemistry, Nursing, Pharmacy).
- Experience in successfully delivering Clinal Trials, preferably in the Medical Device sector.
- Post-graduate qualification in Project Management or Business Administration (Desirable).
- Understanding of FDA and TGA guidelines regarding clinical trials including Good Clinical

Practice guidelines and ISO 14155.
- Demonstrated knowledge and ability to plan, prioritize, and coordinate the completion of

deliverables and tasks, must be highly flexible, have a hands-on approach and be willing to
take initiative.
- Ability to effectively communicate through written and verbal means and constructively

collaborate with colleagues is required.
- Ability to remain professional and positive in all personal interactions, and work with

honesty and transparency while being committed to doing what’s best for our patients,
customers and company.

**Benefits**:

- Comprehensive and competitive remuneration packaging including access to the employee

stock ownership plan and phone allowance.
- A flexible and fun workplace where we understand that your life is more than your job.
- A rare opportunity to work closely alongside world-class colleagues and mentors with

many collective years’ experience in all aspects of medical device development and
commercialisation. All of us share a passion to work collaboratively where every voice is
heard, and your personal professional development is a high priority.
OncoRes is committed to building and fostering an inclusive, diverse workplace. We believe the
differing perspectives and experiences each of us brings inevitably increase innovation and
teamwork, flowing into positive tangible outcomes.

**To Apply**:
Please submit a cover letter and CV addressed to Wes Allen (Clinical Program Manager) to apply.