Job Description

Experienced Study Start-Up Specialist (Global Biopharma FSP) - Home-based in Australia

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Title: Study Site Specialist

Location: Sydney (Preferred), or remote in Australia

Under the guidance of the Sr. Study Site Manager, this position will be responsible for conducting end-to-end site start-up from feasibility to site closures serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.

With the support of ICON right behind you, you will be joining a commercial-stage, global Biotech company, becoming part of a small team in Australia with a vision to grow the team further. With a mission to develop, manufacture and commercialize high-quality medicines for the treatment of cancer and other major diseases, you will be working on first-in-class Oncology trials.

This is a unique opportunity to combine the best of both worlds (Biotech and CRO) to enter a career path that will support your growth and professional development and will broaden your expertise. You will be embedded in our client's study team and have a dedicated ICON line manager to support you.

What You Will Do:

You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.

Key responsibilities include:

• Serve as a primary point of contact to study team on end-to-end study activity.
• Participate in In-House Study team meetings as appropriate.
• Utilize tools to track activities and develop reports.
• Conduct Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
• Conduct site contract/budget negotiations (Confidentiality Agreements, Clinical Trial Agreements and Ancillary Agreements).
• Collect essential documents and track, review quality & upload into systems.
• Support the collection of country and site level intelligence.
• Support and complete Ethics Committee and Regulatory Authority submissions.
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
• Bring sites to Regulatory GreenLight and ensure site fulfillment of all maintenance activities.

Your Profile:

• BA/BS degree in Science or related field.
• At least 5 years’ experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
• Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
• Strong presentation, documentation, and interpersonal skills.
• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
• Excellent oral and written communication skills.
• Proficient in English and local languages as needed.
• Excellent planning and organizational skills with effective time management.
• Excellent interpersonal skills.
• Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
• Thorough understanding of clinical research principles and process.
• Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements- as applicable.
• Goal oriented, self-starter with proven ability to work independently;
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines;
• Comfort with ambiguity; ability to act without having the total picture.
• Ability to proactively identify and solve problems.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here

Are you a current ICON Employee? Please click here to apply