Clinical Trial Senior Manager, Operations

Macquarie University
June 12, 2024
Offerd Salary:$133,989 to $141,514
Working address:N/A
Contract Type:Other
Working Time:Full time
Working type:N/A
Ref info:N/A

• Salary Package: From $133,989 to $141,514 p.a. (HEW Level 9), plus 17% employer's superannuation and annual leave loading • Appointment Type: Full time, continuing (permanent) • Macquarie University (Wallumattagal Campus, North Ryde) location


This newly created role will develop, implement and oversee the delivery of strategic plans for effective resource allocation, professional development and operational excellence of the clinical operations team. By driving strong relationships and process improvements, the successful candidate will ensure optimal patient, investigator, and sponsor experience of clinical trials with the Clinical Trials Unit (CTU). We are seeking someone with extensive management experience at a clinical trial site.

Clinical Trial Managers and the Clinical Trial Laboratory Manager are direct reports, and a large team of Coordinators, Data associates and Lab associates report into those roles.

Reporting to the Head of Clinical Trials Unit, you will be responsible for:

Leadership and Strategy

  • Set the strategic direction for the clinical trials operations group, and together with the CTU Leadership team, contribute to the CTU overall strategic direction.

  • Provide strong and consistent leadership that models high performance and an exemplary team culture focused on growth, longevity and continuous improvement.

  • Develop and implement strategic and operational plans for resourcing clinical trials, ensuring models leverage capabilities and support sustainable growth and the execution of seamless clinical trials.

  • Clinical Trial Oversight and Resource Management :

  • Resource Allocation : Develop and implement a sustainable model to effectively allocate Clinical Trials Coordinators to projects ensuring optimal utilisation of resources across trial activities

  • Trial Support : Provide expert knowledge and collaborate with cross functional teams, sponsors and external stakeholders to oversee and resolve challenges during the course of clinical trials

  • Skills Assessment : Oversee the assessment of skills, competencies, qualifications and interests of staff, to optimise performance and productivity

  • Patient Centricity : Drive a culture focusing on the meeting patient needs and conducting trials in such a way as to facilitate diverse patient participation.

  • Clinical Trial Safety and Data quality: Optimise trial conduct with standards of the highest level of patient safety and data quality.

  • Performance Metrics: Establish and track key performance indicators related to resource allocation, productivity and trial execution, providing regular updates and insights to senior management.

  • Communication and Collaboration : Foster effective communication and collaboration to promote a cohesive and results-driven team environment..

  • 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.

  • 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.

  • Documentation and Reporting: Maintain accurate records of performance discussions, improvement plans, and developmental progress, providing relevant insights to senior management as needed.

  • Stakeholder Management

  • Stakeholder management : Identify key stakeholders and build relationships to drive building efficient, safe and exemplary clinical trial conduct. Streamline processes to facilitate MQ being a CT site of choice for clinicians and sponsors.
  • About You

    You will be a strategic thinker and an experienced leader, bringing both your own clinical trial expertise and a proven ability to harness the expertise of others. You will possess a track record of effective resource planning and allocation with a dual focus of supporting, inspiring and developing clinical trial teams to high performance. You will possess a track record of delivering operational excellence to optimise patient, investigator, program manager and sponsor outcomes whilst managing risk, ensuring best practice and a continuous improvement culture. Your focus on delivering outstanding service quality, operational efficiency and financial sustainability will be key to your success.

    As the successful candidate, you will possess exceptional communication skills and have successfully built and managed effective collaborations and relationships with a wide range of internal and external stakeholders. You will have strong influencing skills and your experience delivering strategic and operational plans in a growth oriented and fast paced environment will set you up to flourish 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.

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

    Selection Criteria

  • A relevant qualification and with significant (e.g. 7+ years) experience in clinical trials site operations including a track record of developing capability and capacity in a team and fostering an environment of support and continuous improvement.

  • Leadership skills including developing and operationalising strategy and managing change for process improvement in a growth environment

  • Strong track record of developing strong and reciprocal stakeholder relationships including effectively collaborating, influencing and building consensus to collectively deliver results

  • Ability to analyse and interpret clinical trial performance metrics and provide sound recommendations for managing complex problems

  • Expert understanding of clinical trial operational procedures and experience developing and implementing resourcing and operational improvements

  • Track record of building and fostering a culture of support, continuous improvement and high performance

  • 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, Head of Clinical Trial Unit at [email protected].

    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: Login to Workday and go to the Careers App > Find Jobs.

    Applications Close:

    12/06/2024 11:59 PM

    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.

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