Clinical Trials Start Up

2 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

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-
- Experience in contract negotiations for agreements and legal documents required for clinical trials- Track record of developing team members and fostering a positive c


  • Clinical Trials Start Up

    Found in: Talent AU C2 - 2 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 ...


  • North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Have you ever dreamed of working in clinical trials? This could be your lucky break! Macquarie University’s world-class Clinical Trials Unit is offering Clinical Trials traineeship opportunities. Gain skills, experience and certifications to kick-start your clinical trials career THE ROLE- Salary Package: $61,243 per annum (HEW Level 3),...

  • Clinical Trials Laboratory Manager

    Found in: Talent AU C2 - 2 weeks ago


    North Ryde, Australia Macquarie University Full time

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

  • Associate Clinical Data Manager

    Found in: Talent AU C2 - 3 days ago


    North Sydney, Australia IQVIA Full time

    Responsibilities: Gather Study Set up requirements through discussion and communication with relevant stakeholders. Perform Database Set up and validation to ensure quality study design for data collection. Support validation of new Device integrations. Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables...

  • Clinical Translational Research Coordinator 1

    Found in: Talent AU C2 - 3 weeks ago


    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...


  • North Adelaide, Australia Adelaide Heel Pain Clinic Full time

    **Receptionist at Specialist Allied Health Clinic** Sports Science Podiatry Pty Ltd North Adelaide, Adelaide SA Medical Administration (Healthcare & Medical) $25 - $29.99 per hour Casual/Vacation Approximately 38 hrs (FULL TIME hours only) + willingness to work Saturdays 9am - 1pm every 2-3 weeks. - Do you have exceptional customer service skills?_ -...


  • North Perth, Australia Brad Hutchinson Hearing Full time

    **Clinic Administrator** An exciting opportunity for a warm and customer focused Clinic Administrator to join our wonderful team, working in our boutique Audiology clinics north of the river. About the role: - Opportunity for full-time or part-time work; - You will be responsible for greeting and assisting patients in a friendly and professional manner; -...

  • Clinic Assistant

    6 days ago


    North Perth, Australia MrWax Grooming Full time

    **Seeking Clinic Assistant / Receptionist.** - A little about us_ We are a small team passionate in helping men find their confidence. We specialise in hair removal (IPL/Laser/Waxing) and skin therapies. We opened our place in 2014 when we noticed that a lot of clinics were women focused and turning men away, so we decided to create a unique, comfortable...

  • Touch Ups Labourer

    5 hours ago


    Williamstown North, Australia Melbourne Surface Repairs Full time

    Melbourne Surface Repairs offers a rare to come by opportunity to work in the field of touch ups, where you can also express your artistic side. Training, till job ready, in the repairs of various materials (timber, veneer, tiles, powder coated aluminium, etc) will be provided, to allow you move towards working on job sites independently under minimum...

  • Touch Ups Labourer

    5 hours ago


    Williamstown North, Australia Melbourne Surface Repairs Full time

    Melbourne Surface Repairs offers a rare to come by opportunity to work in the field of touch ups, where you can also express your artistic side. Training, till job ready, in the repairs of various materials (timber, veneer, tiles, powder coated aluminium, etc) will be provided, to allow you move towards working on job sites independently under minimum...


  • 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 *** **Key Responsibilities**: **Sales Execution** - Achieve monthly, quarterly and annual targets - Provide an accurate sales...

  • Product Specialist III

    Found in: Talent AU C2 - 2 weeks ago


    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....

  • Front of House

    5 hours ago


    North Melbourne, Australia Bobbie Peels Full time

    Bobbie Peels Bobbie Peels is looking for an experienced FOH supervisor to join our team. We are a growing venue with a sharp focus on quality product, service and culture. - Work with hands-on owners/managers who are passionate about excellent hospitality. - Opportunity for advancement - Weekly pay, full award, penalties and bonuses. We are looking for an...

  • Product Specialist III

    Found in: Talent AU C2 - 3 weeks ago


    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...

  • Occupational Therapist

    Found in: Talent AU C2 - 2 weeks ago


    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...

  • Research Fellow

    3 days ago


    North Adelaide, Australia South Australian Health and Medical Research Institute (SAHMRI) Full time

    **Full-time, 3 year contract $90,000 to $100,000 pa, depending on experience** **SAHMRI Women and Kids Theme** - **Fast-track your career by joining a highly successful team of researchers**: - **Strong desire to improve health outcomes through high quality research**: - **Interest in nutrition to improve human health**: - **World-class health and...

  • Country Marketer

    23 hours ago


    North Ryde, Australia Edwards Lifesciences Full time

    Innovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our Marketing teams build lasting,...

  • Speech Pathologist

    Found in: Talent AU C2 - 2 weeks ago


    North Geelong, Australia HealthcareLink Full time

    Job Title: Speech Pathologist - FT/PT/Contractor - Clinic-Based/CommunityLocation: GeelongJob Type: Contractor - FT/PT AvailableSalary: $82-$100/hrWe are seeking a highly skilled and motivated Speech Pathologist to join our team as a Contractor. This is an exciting opportunity to work in a dynamic and supportive environment, helping clients achieve their...

  • Housekeeper

    5 hours ago


    North Ryde, Australia NANNIES & HELPERS Full time

    **Housekeeper** North Ryde Monday to Friday: 3:30 to 8:30/9 PM - Sunday afternoon 6 hours 8 and 11 year old girls A busy professional family of 4 are looking for an amazing Housekeeper to assist with their busy household. The family have two school aged children and need assistance manage the household. **Requirements**: - 2-3 Housekeeper/House...

  • Country Marketer

    Found in: Talent AU C2 - 3 weeks ago


    North Ryde, Australia Edwards Lifesciences Full time

    Innovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our Marketing teams build...