ICON plc

Study Start Up Specialist, Business Operations

ICON plc

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇦🇺 Australia

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Job Level

Mid-LevelSenior

About the role

  • 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.

Requirements

  • 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.
  • Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams.
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
feasibility assessmentssite identificationsite contract negotiationregulatory compliancesubmission preparationinformed consent formsclinical study start-up
Soft skills
communicationcollaborationexpertiseinsight provision
Certifications
Bachelor's degree