Clinical Trials Program Manager - Oncology x 2

at  Macquarie University

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 oncolog

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.
As the successful candidate, you will have demonstrated leadership ability with a track record of leading by example, developing capability and fostering a culture of best practice and continuous improvement. Your passion and service ethic across all aspects of the clinical trial lifecycle including patient management and care coupled with your focus on delivering outstanding quality, operational efficiency and financial sustainability will set you up to succeed in this important role.
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 innovation.
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To Apply

To be considered for this position, applicants must address the selection criteria below in a separate document and upload the document/cover letter along with a copy of your resume.

• Specify the role you are applying for i.e. Program Manager for Phase I solid tumour oncology trials or Program Manager for Breast and GU Oncology trials
• A degree in life sciences, health or equivalent experience in clinical trials coupled with extensive (e.g. 5+ years) experience working in patient facing roles on industry sponsored oncology clinical trials
• Demonstrated comprehensive knowledge and expertise in oncology trials with specific expertise in one of the two therapeutic areas of Phase 1 solid tumour oncology and/or breast and genitourinary oncology
• Excellent track record of building consensus and leading colleagues, clinicians, trial sponsors, trial participants and other stakeholders to consistently deliver high quality and sustainable trial outcomes
• A track record of developing capability through mentoring, leading by example and fostering a positive and supportive environment where colleagues feel heard and supported
• Ability to lead and deliver quality outcomes on projects in a complex and fast paced clinical-trial environment
• Note: This position requires a criminal history check, working with children check, immunisations and vaccinations (including Category A) and a good clinical practice certificate

Specific Role Enquiries: Nicola Chapman at
nicola.chapman@mq.edu.au
.
If you’re already part of the Macquarie Group (MQ University, U@MQ, MQ Health, MGSM), you’ll need to apply through your employee Workday account. To apply for this job:
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Applications Close:
16/06/2024 11:59 PM
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