Clinical Trials Program Manager

PRIMARY DETAIL

Job Requirements: WWCC, Criminal History Check, Immunisations/Vaccinations (Category A) & Good Clinical Practice Certificate

THE ROLE

We are seeking two talented and motivated individuals with extensive clinical trial experience to build a portfolio of clinical trials in the oncology area of:
- Phase 1 solid tumour or- Breast and genitourinary oncology

As the program manager, you will work in a matrix environment with a supportive culture that values team-work and innovation. You will lead the planning and execution across the trial lifecycle including ensuring adherence to the highest standards of safety, efficiency, quality, and cost-effectiveness. You will also oversee the coordination, and management, of trial activities including developing and implementing detailed project plans for recruitment strategy, timelines, data management, resource management, reporting metrics, risk assessment & mitigation. Reporting to the Head of the Clinical Trials Unit with a dotted line to the Principal Investigators, you will be responsible for:
Leadership and Strategy- Leadership: In collaboration with the CTU Executive contribute to strategic planning, team culture and CTU leadership.- Strategic Trial Planning: Lead the strategic planning and execution of future clinical trials, ensuring alignment with organisational goals and regulatory requirements

Business Development & Stakeholder Management- Feasibility Documentation: Assessing the viability and potential impact of new trials, ensuring that timelines, recruitment and implementation predictions are accurate.- Stakeholder Liaison: Establish and maintain effective communication channels with external stakeholders, sponsors, and regulatory authorities, fostering collaborative relationships to support trial success- Stakeholder management: Develop and foster relationships with Clinicians and Investigators to ensure MQ CTU is their CTU of choice for trial implementation and their clinical trial support is optimal.- Trial Planning: Assist in the development of detailed program as well as individual project plans including identifying and mitigating risks to patients, staff and the organisation.

Clinical Trial Implementation and Oversight:
- Trial Oversight: Oversee and/or coordinate, implement and monitor how clinical trials in the Program portfolio are conducted to ensure they are consistently implemented safely, efficiently, cost-effectively and with high quality.- Training: Train, coach and develop CTU staff, clinicians and vendors in the conduct of protocols and the therapeutic area to optimise the conduct of clinical trials in the Program. -
- Resource Allocation: Collaborate closely with the Clinical Trials Senior Manager and Clinical Trial Managers to identify resource needs and ensure clinical trials have adequate staff resources and that staff are adequately supported to provide optimal clinical trial implementation.- Resource Management: Support the clinical trial staff working on Program studies with day-to-day trial activities, delegation of tasks, oversight of workload and feedback of their performance liaising closely with their Clinical Trial Manager.- Participant Recruitment: Oversee the recruitment process for clinical trial participants, ensuring adherence to approved protocols and ethical considerations.- Participant care, oversight, and centricity: ensure optimal participant care and safety and ensure their needs are prioritised.- Quality Assurance: Ensure adherence to clinical trial protocols, GCP standards and sponsor requirements by reviewing and resolving complaints, issues, or discrepancies, escalating concerns when necessary.

About You

You will be a strategic thinker and planner with excellent relationship management skills and an ability to influence, build consensus and lead others to deliver program outcomes. You will possess comprehensive knowledge in oncology (and the specific therapeutic area) coupled with a strong track record of project managing complex industry sponsored oncology trials at trial sites. You will be a strong communicator and have successfully built and managed effective collaborations and relationships with clinicians, sponsor organisations and a wide range of internal and external stakeholders.

About Us

The

Clinical Trials Unit (CTU)

is part of the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University. FMHHS also has the Macquarie Medical School, the Macquarie University Private Hospital, and runs patient clinics, labs, imaging and a pharmacy all on campus in close proximity to support clinical trials, and support providing patients with access to state of the art treatments. The CTU undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of over 60 staff (managing over 120 trials) are a close knit inclusive team with a supportive culture that values team work and in