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About the Role

ICON is a global healthcare intelligence and clinical research organisation focused on accelerating the delivery of new medicines and treatments to patients. This role serves as the primary point of contact for study sites, managing end-to-end site start-up activities from feasibility to closure.

Responsibilities

• Manage day-to-day site start-up and activation activities.
• Serve as a primary point of contact to the study team on end-to-end study activity.
• Participate in In-House Study team meetings.
• Utilize tools to track activities and develop reports.
• Conduct Feasibility activities including the negotiation and collection of Confidentiality Agreements and 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.
• 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.
• Bring sites to Regulatory GreenLight and ensure site fulfillment of all maintenance activities.

Requirements

• BA/BS degree in Science or related field.
• At least 5 years’ experience in site start-up and contract management in a pharmaceutical company or 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.
• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Skills

• MS Office (Word, Excel, and PowerPoint)
• MS Project
• Email
• Internet
• Presentation skills
• Documentation skills
• Interpersonal skills
• Oral communication skills
• Written communication skills
• Planning skills
• Organizational skills
• Time management skills

Location

• Home-based in Australia
• Sydney (Preferred)
• Remote in Australia

Work Type

• Home-based
• Remote

Experience Level

• At least 5 years’ experience in site start-up and contract management

Education Level

• BA/BS degree in Science or related field

Benefits

• 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

About the Company

• 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.
• ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
• You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.

Equal Opportunity

• 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.