Clinical Trials Start Up

4 weeks ago


North Ryde, Australia Macquarie University Full time

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 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. .



  • North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL - Appointment type: Full time, 2 year fixed term - Salary Package: From $80,753 to $91,815 p.a. (HEW 5), plus 17% employers superannuation and annual leave loading - 35 hour work week with opportunities for flexible work - Location: Macquarie University (North Ryde) location THE ROLE The Role The Clinical Trials Associate (CTA) is...


  • North Sydney Council, Australia IQVIA Full time

    Job Overview:We are currently seeking Clinical Trials Assistants ( CTA) to join our Functional Service Partnerships team in a client facing role. This role does require onsite with our client 2 days a week in North Ryde. As a vital part of our team, our Clinical Trials Assistants( CTA) perform daily administrative tasks to support to clinical projects and...

  • Medical Advisor

    4 weeks ago


    North Ryde, Australia Healthcare Professionals Group Full time

    **About the company** This leading pharmaceutical company is at the forefront of innovation with an incredibly strong pipeline. Combining passion with research and development they have discovered many of the most utilised medicines across various therapeutic portfolios. This enables them to be instrumental in contributing to the health and well-being of...


  • North Adelaide, Australia Vanderbilt University Medical Center Full time

    Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of diverse individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your...

  • Site Care Partner

    4 weeks ago


    North Ryde, Australia Parexel Full time

    North Ryde, New South Wales, Australia **Job ID** R0000020554 **Category** Clinical Trials **ABOUT THIS ROLE**: **Role Summary** The Site Care Partner is the main Client point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator...


  • Ryde, Australia Silver Search Full time

    **PA support to Surgeon**: - **Full time, 1 day/week from home (optional)**: - **Ryde Location** A unique opportunity for an experienced Personal Assistant to provide exceptional administrative support to a busy surgeon. **Your key responsibilities include**: A varied role requiring strong attention to detail and high level communication skills. You will...

  • Research Assistant

    4 weeks ago


    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL The Neuroproteomics research group within the Centre for Motor Neurone Disease (MND) at Macquarie University (Sydney) is looking for a Research Assistant. THE ROLE- Salary Package: from $76,908 -$87,443 per annum (HEW level 5) plus 17% employer’s superannuation contribution and annual leave loading- Appointment Type: Full time, fixed term...


  • North Sydney, Australia Amazon Web Services Australia Pty Ltd Full time

    AWS Sales, Marketing, and Global Services (SMGS) is responsible for driving revenue, adoption, and growth from the largest and fastest growing small- and mid-market accounts to enterprise-level customers including public sector. The AWS Global Support team interacts with leading companies and believes that world-class support is critical to customer success....

  • Clinical Lead

    7 days ago


    North Turramurra, Australia LDK Healthcare Full time

    **About Us** LDK is leading change for Senior Australians. Working with us you can expect a 5 star employee experience, industry leading employee engagement scores and growth through our LDK Academy. Our people are passionate, live and breathe the values of love, decency and kindness every day, and have a whole lot of fun doing it! **About the Role** You...


  • North Parramatta, Australia Sparks Developmental Specialists Full time

    **About us** This is an exciting opportunity to support a team of passionate therapists who are dedicated to working with children and their families. **About the role**: You will be responsible for overseeing the clinic's daily operations, from managing staff to handling client interactions. You will be an integral part of growth and expansion. **Duties...


  • North Ryde, Australia Demant Full time

    Who is Audika?- #LI-TS1#LI-ON#audika_Australia- Audika is part of Demant, a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss. Worldwide the group employs more than 17,500 staff in more than 30 countries and distributes hearing healthcare and intelligent audio solutions to people in more than 130...


  • North Parramatta, Australia Sparks Developmental Specialists Full time

    **About us** This is an exciting opportunity to lead and support a team of passionate therapists who are dedicated to working with children and their families, with the ultimate goal of increasing each child's participation in everyday activities and experiences. **About the role**: You will be responsible for overseeing the clinic's daily operations, from...

  • Clinical Manager Wat

    4 weeks ago


    North Sydney, Australia Assure Programs Full time

    We are looking for an engaging, collaborative and driven Clinical Manager with strong commercial acumen to lead and develop our Assure Workplace Advisory Team (WAT). You will and lead a professional high-performing team in an organisation that values your growth, skills, and passion. You will be tasked with ensuring the clinical and operational excellence...


  • North Ryde, Australia Thermo Fisher Scientific Full time

    **Job Title**: Product Specialist, Clinical & Pharmaceutical Microbiology NSW **Reports to**: Commercial Leader, Microbiology **Group / Division**: Thermo Fisher Scientific ANZ **Career Band**: 06 **Position Location**: Sydney **Position Summary**: **Key Responsibilities**: **Sales Execution** - Achieve monthly, quarterly and annual targets - Provide an...


  • North Ryde, Australia Demant Full time

    **Who is Audika?** - #LI-TS1 #audika_Australia #LI-HYBRID - Audika is part of Demant, a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss. Worldwide the group employs more than 17,500 staff in more than 30 countries and distributes hearing healthcare and intelligent audio solutions to people in more...


  • Ryde, Australia Demant Full time

    Who is Audika?- Audika is part of Demant, a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss. Worldwide the group employs more than 17,500 staff in more than 30 countries and distributes hearing healthcare and intelligent audio solutions to people in more than 130 countries.- In Australia, Audika has...


  • North Ryde, Australia Thermo Fisher Scientific Full time

    Job DescriptionJob Title: Product Specialist, Clinical & Pharmaceutical Microbiology NSWReports to: Commercial Leader, MicrobiologyGroup / Division: Thermo Fisher Scientific ANZCareer Band: 06Position Location: SydneyPosition Summary: The Product Specialist is primarily responsible for lead generation and sales closure within the Microbiology Business Areas....


  • North Ryde, Australia Thermo Fisher Scientific Full time

    : Sales Execution • Achieve monthly, quarterly and annual targets • Provide an accurate sales forecast for the Clinical & Pharma Microbiology business areas • Craft and implement effective business territory plans • Use data analysis tools to optimise sales and margin metrics for customer accounts • Ensure feedback including win/loss...


  • North Geelong, Australia HealthcareLink Full time

    Job Title: Occupational Therapist - Contractor - Clinic-Based/CommunityLocation: GeelongJob Type: ContractorSalary: $82-$100/hrWe are seeking a highly skilled and motivated Occupational Therapist to join our team as a Contractor. This is an excellent opportunity to work in a dynamic and supportive environment, helping clients achieve their goals and improve...


  • Balwyn North, Australia Children's Dentistry Full time

    **About the business** We are a very established and well-respected **specialist paediatric dental practice** in the eastern suburbs of Melbourne. Our practice is state-of-the-art, and purpose built for managing children Our long-standing team are absolutely passionate about working with children. In addition to working at the practice, each one of our...