Macquarie University
health
ClinicalTrialsProgramManager-Non-Oncology
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optimal for Senior candidates.
“Clinical Trials Program Manager - Non-Oncology at Macquarie University. Skills: clinical trials experience, program manager, leadership, strategic planning, stakeholder management, trial oversight, resource allocation, participant recruitment, quality assurance. oversee and build a portfolio of trials. ensure that Macquarie University hospital and clinic patients have access to a wide range of clinical trials”
What You'll Achieve.
ensure that Macquarie University hospital and clinic patients have access to a wide range of clinical trials; ensure that the trials are consistently undertaken to the highest quality standards; ensure adherence to the highest standards of safety, efficiency, quality, and cost-effectiveness; consistently deliver high quality and sustainable trial outcomes; delivering outstanding quality, operational efficiency and financial sustainability
Industry & Context.
help problem solve; risk assessment & mitigation
criminal record check, working with children check, qualification check, vaccination check
What They're Looking For.
Must Have
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, criminal record, working with children, qualification and vaccination checks
What You'll Do.
oversee and build a portfolio of trials
ensure that Macquarie University hospital and clinic patients have access to a wide range of clinical trials
ensure that the trials are consistently undertaken to the highest quality standards
build and support a portfolio of about 40 clinical trials across two to four therapeutic areas with 6 to 12 specialists
lead the planning and execution across the trial lifecycle
ensure adherence to the highest standards of safety
and cost-effectiveness
oversee feasibility and then the coordination
develop and implement detailed project plans for recruitment strategy
risk assessment & mitigation
help problem solve and provide expertise for the trial coordinators assigned to the trials
contribute to strategic planning
team culture and CTU leadership
lead the strategic planning and execution of future clinical trials
assess the viability and potential impact of new trials
establish and maintain effective communication channels with external stakeholders
and regulatory authorities
develop and foster relationships with Clinicians and Investigators
assist in the development of detailed program as well as individual project plans
identify and mitigating risks to patients
staff and the organisation
oversee and/or coordinate
implement and monitor how clinical trials in the Program portfolio are conducted
coach and develop CTU staff
clinicians and vendors in the conduct of protocols and the therapeutic area
collaborate closely with the Clinical Trials Senior Manager and Clinical Trial Managers to identify resource needs
ensure clinical trials have adequate staff resources and that staff are adequately supported
support the clinical trial staff working on Program studies with day-to-day trial activities
oversight of workload and feedback of their performance
oversee the recruitment process for clinical trial participants
ensure optimal participant care and safety and ensure their needs are prioritised
ensure adherence to clinical trial protocols
GCP standards and sponsor requirements by reviewing and resolving complaints
escalating concerns when necessary
How You'll Work.
Team & Collaboration
Working closely with our passionate, and engaged specialists conducting clinical trials; work in a matrix environment with a supportive culture that values teamwork and innovation; In collaboration with the CTU Executive contribute to strategic planning, team culture and CTU leadership; Establish and maintain effective communication channels with external stakeholders, sponsors, and regulatory authorities, fostering collaborative relationships to support trial success; 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; Collaborate closely with the Clinical Trials Senior Manager and Clinical Trial Managers to identify resource needs; 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; building consensus and leading colleagues, clinicians, trial sponsors, trial participants and other stakeholders to consistently deliver high quality and sustainable trial outcomes; fostering a positive and supportive environment where colleagues feel heard and supported
Communication Scope
excellent relationship management skills; ability to influence; build consensus; communicator; establish and maintain effective communication channels with external stakeholders, sponsors, and regulatory authorities; develop and foster relationships with Clinicians and Investigators
Process & Methodology
program management, project management, planning and execution across the trial lifecycle, developing and implementing detailed project plans for recruitment strategy, timelines, data management, resource management, reporting metrics, risk assessment & mitigation, assist in the development of detailed program as well as individual project plans
Full Job Description
## **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******T** he 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_ * **Leader
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