Clinical Trial Manager

Clinical/Medical Research (Healthcare & Medical)

• Salary Package: From $119,056 to $132,475 p.a. (HEW Level 8), plus 17% employer's superannuation and annual leave loading.
  
• Appointment Type: Full time, continuing contract
  
• Macquarie University (Wallumattagal Campus, North Ryde) location

The Role
We are seeking a motivated and experienced people manager with extensive clinical trial experience to lead and develop a high performing team. This is an excellent role for someone with a shared passion for providing best practice clinical trial support and also mentoring a team of professionals to deliver the highest standards of patient care and safety. Reporting to the Head of the Clinical Trials Unit, as the successful applicant you will:

Leadership and Strategy

• In collaboration with the CTU Executive contribute to strategic planning, team culture and CTU leadership.
• Provide strategic business partnering and decision support for future trials and operations

Clinical Trial Oversight and Resource Management :

• Trial Feasibility & Budget: Contribute to feasibility assessments, support selection and budget negotiation and ensure that timelines, recruitment and implementation predictions are accurate.
• Trial Oversight: Oversee and/or coordinate, implement and monitor how clinical trials assigned to your team members are conducted, in accordance with GCP, legislative requirements, and trial protocols to ensure Clinical Trials are consistently implemented safely, efficiently, cost-effectively and with high quality.
  
• Vendor Management: Liaise with relevant parties of Macquarie University, Macquarie University Hospital and external organisations to manage and support quality and service standards of clinical trials.
  
• Training: Develop and conduct education and research programs for the CTU and educational programs for individual CTU staff members, clinicians and vendors providing services supporting CTU trial conduct to drive a culture of continuous improvement and quality customer service.
  
• Resource Allocation: Collaborate closely with the Program Managers and Clinical Trial Managers to identify resource needs across multiple trials and ensure clinical trials have adequate staff resources allocated and that staff are adequately supported to provide optimal clinical trial implementation.
  
• Standard Procedures: Develop and ensure adherence to clinical trial unit policies and standard operating procedures, and problem solve issues arising during the implementation of clinical trials.

People Management:
Develop, lead and manage a high performing team through:

• Oversee recruiting and training clinical trial staff to ensure consistency and scalability to meet clinical trial demand
  
• Staff Development: Provide coaching, mentorship and guidance and help with setting meaningful development and career goals to enhance skills and navigate professional challenges
  
• Managing Performance: Effectively manage individual and team performance and create an environment that motivates team members to perform at their best.
  
• Goal Setting: Assist direct reports in setting clear and achievable performance goals.
  
• Skills Development: Identify training, learning and development opportunities that enable team members to acquire new stills and competencies to enhance their capabilities
  
• Feedback Facilitation: Promote a culture of constructive feedback by encouraging open dialogue, facilitating feedback sessions, and fostering a safe environment for communication.
  
• Recognition and Appreciation: Recognise and celebrate individual and team achievements, fostering a positive and motivated work atmosphere.

Stakeholder Management

• Stakeholder management: Develop and foster relationships with Sponsors and Clinical Research Organisations as well as Clinicians and Investigators to ensure MQ CTU is their CTU of choice for trial implementation.

About You
You will be an excellent communicator with strong organisational, planning and execution skills. You will possess excellent stakeholder management and influencing skills both within a clinical trials team and externally. You will have an excellent reputation as a respected practitioner underpinned by your approach and knowledge obtained through extensive site trial experience.

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 70 staff (managing over 140 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. Since our foundation 54 years ago, we have aspired to be a different type of university. Over the years, we've grown to become the centre of a vibrant local and global community. Connect with us today .

To Apply
To be considered for this position apply online and attach your resume and a separate cover letter that outlines how you meet the following selection criteria:

• A relevant qualification with significant (e.g. 5+ years) experience in clinical trials site operations including working as a Clinical Trial Coordinator on industry sponsored phase I trials or equivalent
  
• Excellent working knowledge of clinical trials processes and Australian regulatory requirements
  
• Superior consultation and collaboration skills including a demonstrated ability to develop relationships with diverse range of stakeholders to jointly deliver clinical 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

Role Requirements: this position requires a criminal history check, working with children check, immunisations and vaccinations (including Category A) and a good clinical practice certificate

Please note this position is only open to Australian citizens, permanent residents and those currently residing in Australia with full working rights.

Specific Role Enquiries: Louise Archer at louise.archer@mq.edu.au .

Applications Close: Sunday 14th July at 11:55 PM (AEST)

Diversity and Inclusion

Innovation and ingenuity thrive at Macquarie University when diversity, equity and inclusion take centre stage. At the University, we embrace a culture where diversity of background, experience and perspective are fundamental to our success.

We do not discriminate on gender identity, age, culture, disability, sexuality, Indigeneity, family and caring responsibilities or religion. See our journey towards leadership in Equity, Diversity and Inclusion in Higher Education.

Flexible Work
At Macquarie, we believe by providing flexibility in when, where and how work is done, we can support our staff to manage their personal commitments, while optimising their work performance and contributions to the University. See how we lead in flexible work to enable an outcome focused and inclusive workplace. To learn more about our culture and hiring process, explore our Candidate Resource Hub .

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university: one unbound by ivory towers and sandstone walls. Rather, we are focused on fostering collaboration between students, academics, industry and society, encouraging all to traverse the boundaries of their own perspective and affect change.

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university: one unbound by ivory towers and sandstone walls. Rather, we are focused on fostering collaboration between students, academics, industry and society, encouraging all to traverse the boundaries of their own perspective and affect change.

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