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 ROLEWe 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 StrategyIn collaboration with the CTU Executive contribute to strategic planning, team culture and CTU leadershipProvide strategic business partnering and decision making support for Start Up and regulatory matters including future trialsClinical 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 processesEnsure Start Up and regulatory procedures and processes support consistent and efficient feasibility assessments; trial Start Up; and budgeting for Clinical Trials.People ManagementDevelop, 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 environmentOversee the allocation of staff workload, taking into consideration sponsor and PI priorities and timelines as well as staff capabilities and development requirements.Stakeholder ManagementIdentify key stakeholders and build relationships to drive building strategic Clinical Trials portfoliosAbout YouYou 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 UsThe 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. .To ApplyTo 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 proceduresDeep 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 settingExperience in contract negotiations for agreements and legal documents required for Clinical TrialsTrack record of developing team members and fostering a positive culture which motivates individuals and teams to deliver high quality services and perform at their bestExcellent consultation and collaboration skills including the demonstrated ability to develop relationships with a diverse range of stakeholdersNote: This position requires a criminal record, working with children and qualification checks.Specific Role Enquiries: Nicola Chapman, Head of Clinical Trials Unit via .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. 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Find Jobs.Applications Close: 05/05/2024 11:59 PMDiversity and InclusionInnovation 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 in Higher Education.Flexible WorkAt 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 to enable an outcome focused and inclusive workplace. To learn more about our culture and hiring process, explore our .