Clinical Trials Program Manager

PRIMARY DETAIL

• Salary Package: From $126,306 to $140,543 p.a. (HEW Level 8), plus 17% employer's superannuation and annual leave loading.
• Appointment Type: Full time, continuing contract.
• 35 hour working week with opportunities for flexible working arrangements such as a 9 day fortnight
• Macquarie University (Wallumattagal Campus, North Ryde) location

A brand-new specialist role in clinical trials! Do you have extensive clinical trials experience with expertise in therapeutic areas such as respiratory diseases, cardiology and/or gastroenterology? Working closely with our passionate, and engaged specialists conducting clinical trials, this role will oversee and build a portfolio of trials to ensure that Macquarie University hospital and clinic patients have access to a wide range of clinical trials and that the trials are consistently undertaken to the highest quality standards.

About the Role

We are seeking a talented and motivated individual with extensive clinical trial experience to build and support a portfolio of about 40 clinical trials across two to four therapeutic areas with 6 to 12 specialists.

As the program manager, you will work in a matrix environment with a supportive culture that values teamwork 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 feasibility and then 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. You will help problem solve and provide expertise for the trial coordinators assigned to the trials.

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 Us

The Clinical Trials Unit (CTU) is part of the MQ Health and 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 100 staff (managing over 180 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives.

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 or develop comprehensive knowledge in the specific therapeutic areas coupled will have a strong track record of project managing complex industry sponsored 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.

Selection Criteria

• 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 clinical trials
• Demonstrated comprehensive knowledge and expertise in clinical trials implementations including phase I, with specific expertise in at least one of the following therapeutic areas: respiratory, GI and/or cardiovascular device trials
• 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 record, working with children, qualification and vaccination checks.

To Apply

To be considered for this position:

• Specify the role you are applying for i.e. Clinical Trials Program Manager
• Applicants must address the selection criteria below in a separate document and upload the document/cover letter along with a copy of your resume.

Applications Close: Wednesday 27th of May at 11:55pm (AEST)

For a confidential conversation about the role please contact Nicola Chapman, Head of Clinical Trials at nicola.chapman@mq.edu.au