Clinical Trials Start Up & Regulatory Manager

PRIMARY DETAIL

• Salary Package: From $115,030 to $127,995 p.a. (HEW Level 8), plus 17% employer's superannuation and annual leave loading
• Appointment Type: Full time, continuing (permanent)
• 35 hour working week with opportunities for flexible working arrangements
• Macquarie University (Wallumattagal Campus, North Ryde) location

THE ROLE

We are seeking a committed, collaborative and experienced clinical Trial Start-Up and Regulatory Specialist to join our supportive and inclusive Clinical Trial Unit. This important role manages a team of Start-up and Regulatory Associates and provides strategic start up and regulatory advice and support for sponsored and investigator initiated Phase I - IV clinical trials. Reporting to the Head of Clinical Trials Unit, you will be responsible for:

Leadership and Strategy

• In collaboration with the CTU Executive contribute to strategic planning, team culture and CTU leadership

• Provide strategic business partnering and decision making support for start up and regulatory matters including future trials

Clinical Trial Regulatory Oversight and Support :

• Provide advice on research ethics or integrity issues and clinical trial regulations and oversee MQ clinical trial HREC and governance submissions Ensure MQ clinical trial documentation is compliant with GCP, and legislative requirements.

• Oversee trial budgets to ensure the continued viability and sustainability of the CTU and maintain oversight of contract executions to ensure compliance with MQ processes and policies to mitigate risk to the organisation.

• Ensure management, coaching and development of staff within the Clinical Trials Start up and Regulatory team enhances CTU operations and drives a culture of continuous improvement, and quality and ensures optimal clinical trial regulatory processes and timelines.   

• Streamline regulatory, budget development and contract execution processes

• Ensure start up and regulatory procedures and processes support consistent and efficient feasibility assessments; trial start up; and budgeting for clinical trials.

People Management

• Develop, lead and manage a high performing team through staff development, performance management, goal setting and skills development.

• Promote a culture of constructive feedback by encouraging open dialogue, facilitating feedback sessions, and fostering a safe environment for communication.

• Ensure individual and team achievements are recognised and celebrated and foster a positive and motivated work environment

• Oversee the allocation of staff workload, taking into consideration sponsor and PI priorities and timelines as well as staff capabilities and development requirements. 

Stakeholder Management

• Identify key stakeholders and build relationships to drive building strategic clinical trials portfolios

About You

You will be a proactive, caring and supportive manager with a track record of inspiring and developing a team. You will have excellent working knowledge of clinical trials and have experience in developing and implementing processes to support streamlined clinical trial start up, feasibility and regulatory activities across multiple therapeutic areas.

You will be able to effectively collaborate with and influence stakeholders both within the clinical trials team and externally to achieve trial objectives in a fast-paced setting.

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 along with a copy of your resume.

• Degree in life sciences, health, or equivalent or equivalent experience and substantial experience working in clinical trials coupled with extensive knowledge of Australian Clinical Trial regulations and experience in clinical start up procedures

• Deep and broad understanding of regulation and regulatory frameworks for clinical trials (e.g. GCP), sound working knowledge of ethics and integrity issues and a successful strong track record of actively managing and applying these in a clinical trial setting

• Experience in contract negotiations for agreements and legal documents required for clinical trials

• Track record of developing team members and fostering a positive culture which motivates individuals and teams to deliver high quality services and perform at their best

• Excellent consultation and collaboration skills including the demonstrated ability to develop relationships with a diverse range of stakeholders

Note: This position requires a criminal record, working with children and qualification checks.

Specific Role Enquiries: Nicola Chapman, Head of Clinical Trials Unit via [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:

05/05/2024 11:59 PM

Diversity and Inclusion

19/04/2024