Study Start Up Specialist, Business Operations

ICON plc

. Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities .

Posted 11/6/2026full-timeRemote • AustraliaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in conducting feasibility assessments and site contract negotiations while ensuring compliance with regulatory and ethical standards. Proficient in coordinating clinical study start-up activities and preparing essential documentation for clinical trials.

Highest-signal resume keywords

Clinical Study Start-Up ExperienceRegulatory Submission CoordinationSite Contract NegotiationFluency In Local Language And EnglishBachelor's Degree In Medical/Science

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Feasibility AssessmentSite IdentificationMaster And Country Specific Subject Information SheetsInformed Consent FormsClinical Trial Initiation

Industry Keywords

Study Start UpClinical TrialsRegulatory BodiesEthics CommitteesSite Distribution Planning

About the role

Key responsibilities & impact

Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities
Provide expertise to Study Start Up team leads and project teams
Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies
Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms
Support the Study Start Up Team Lead in developing and executing the plan for country and site distribution
Conduct SSU activities in assigned countries to support the smooth initiation and progress of clinical trials

Requirements

What you’ll need

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
Legal right to work in the country where the role is based

Benefits

Comp & perks

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