Study Start Up Specialist, Business Operations

ICON Clinical Research; Sydney; Remote; AUD 70,000 - 95,000; Full time

Benefits offered by this job

Base salary and performance incentives

Health and wellbeing programs

Retirement/pension plans

Life insurance & disability cover

Employee assistance programs

Training and career development

Job summary

ICON Strategic Solutions in Australia is seeking a Study Start Up Associate to join a fast-paced, sponsor-dedicated team. You will support the Study Start Up Team Lead in developing and executing plans for country and site distribution, ensuring SSU activities run smoothly across trials.

Requirements include a Bachelor's degree or local equivalent, at least 3 years in clinical study start-up, and fluency in the local language and English.

Qualifications

• Bachelor's degree or local equivalent in medical/science field or related discipline.
• 3+ years of experience or understanding of clinical study start-up requirements and activities.
• Fluency in the local language and English is essential for international collaboration.

Responsibilities

• Drive study initiation activities including feasibility, site identification and site contracting.
• Provide SSU expertise to study leads and project teams to support success.
• Coordinate regulatory submissions to authorities and ethics boards to ensure compliance.
• Support patient safety by contributing to information sheets and informed consent reviews.

Skills

Clinical Start-Up knowledge

English fluency

Education

Bachelor's degree or local equivalent

Job description

Study Start Up Specialist, Business Operations

Study Start Up Associate II, Home-based in Australia

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are currently seeking a Study Start Up Associate to join our diverse and dynamic team. As a Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and executing the plan for country and site distribution. Your expertise and dedication will be essential in efficiently conducting SSU (Study Start Up) activities in the assigned countries, ensuring the smooth initiation and progress of clinical trials.

What you will be doing:

• Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Your Profile:

• A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.
• At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field.
• Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams.

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

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.

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 requesthere.