Study Start-up Lead

7 days ago

Sydney, Australia ICON plc Full time

**Clinical Trial - Study Start-Up Lead**

**Location: Sydney, Australia (hybrid)**

As a Study Start-Up Lead, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on leveraging cutting-edge science to make a positive impact in the therapeutic areas of cancer, cardio-metabolic, vaccines, and oncology, which makes up 70% of their portfolio. If you’re looking to make difference, this could be the career destination for you.

**What you will be doing**:

- Oversight of country and site budgets incl. CTRA negotiation, payment reconciliation at study close-out and forecasting
- Execution and oversight of clinical trial country submissions and approvals
- Development of local ICF
- Management of country deliverables, timelines and results
- Ownership of local regulatory and finance compliance

**You are**:

- Bachelor's Degree
- Extensive experience in study start
- up gained within CRO, pharma or biotech
- Skilled knowledge of contract and budget negotiations and local submission and approval processes
- Excellent problem solving, time-management and stakeholder management skills
- Positive attitude and influencing skills
- Willing to work in the office 2-3 days/ week

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  • Study Start-up Lead

    7 days ago

    Sydney, Australia ICON Full time

    **Clinical Trial - Study Start-Up Lead** **Location: Sydney, Australia (hybrid)** As a Study Start-Up Lead, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on...

  • Study Start-Up Lead

    6 days ago

    Sydney, New South Wales, Australia Icon Plc Full time

    **Clinical Trial - Study Start-Up Lead****Location: Sydney, Australia (hybrid)**As a Study Start-Up Lead, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on leveraging...

  • Study Start-Up Lead

    6 days ago

    Sydney, New South Wales, Australia Icon Full time

    **Clinical Trial - Study Start-Up Lead****Location: Sydney, Australia (hybrid)**As a Study Start-Up Lead, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on leveraging...

  • Study Start Up Associate

    2 weeks ago

    Sydney, Australia ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate

    1 week ago

    Sydney, New South Wales, Australia Icon Plc Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • SSO Study Start-up Manager

    2 weeks ago

    Sydney, New South Wales, Australia Novartis Contract Manufacturing Full time

    OverviewThe SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with...

  • Sso Study Start-Up Manager

    2 weeks ago

    Sydney, New South Wales, Australia Novartis Pharma Schweiz Full time

    OverviewThe SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country.Leads all SSU activities of assigned projects in close collaboration with SSO...

  • SSO Study Start-up Manager

    2 weeks ago

    Sydney, New South Wales, Australia Novartis Pharma Schweiz Full time

    OverviewThe SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with...

  • Sso Study Start-Up Manager

    1 week ago

    Sydney, New South Wales, Australia Novartis Full time

    Summary The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country.Leads all SSU activities of assigned projects in close collaboration with SSO...

  • SSO Study Start-up Manager

    2 weeks ago

    Sydney, New South Wales, Australia Novartis Full time $104,000 - $130,878 per year

    SummaryThe SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO...