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Skills: Study start-up, Regulatory submissions, TFDA, EC/IRB, Site activation
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Full-time
bachelor degree
Competitive base salary, Performance related incentives, Medical coverage, Dental coverage, Vision coverage, Retirement and pension plans
Posted 5d ago
~40 hrs/week
Responsibilities
Lead and manage country-level study start-up activities, including regulatory submissions and site activation deliverables for global clinical trials. Collaborate with cross-functional teams to ensure compliance with ICH-GCP and local regulations while driving study milestones.
Requirements
Requires a Bachelor's degree in Life Sciences and at least 2 years of experience in regulatory submissions, specifically with TFDA or EC/IRB. Candidates must possess strong knowledge of clinical trial systems and excellent project management skills.
Full job description
Taiwan - FSP - (Senior) Study Start Up associate - Hybrid
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 Strategic Solutions is seeking an experienced (Senior) Study Start-Up Associate to support global clinical trials in Taiwan. In this role, you will lead country-level study start-up activities, regulatory submissions, and site activation deliverables while partnering with local and global stakeholders to deliver studies compliantly and efficiently. The final job title may be adjusted based on the selected candidate's experience and qualifications.
What You Will Do
Lead and manage country-level study start-up activities for global clinical trials.
Prepare, review, and oversee TFDA and EC/IRB initial submissions and approvals.
Drive site activation timelines, regulatory documentation, CTMS updates, and eTMF compliance.
Collaborate with CRAs, study teams, regulatory, and cross-functional stakeholders to achieve study start-up milestones.
Proactively identify risks, resolve issues, and ensure compliance with ICH-GCP and local regulations.
Your Profile
Bachelor's degree in Life Sciences or a related discipline.
Experience supporting global clinical trials.
Minimum 2 years of regulatory submission experience, including hands-on experience managing initial TFDA or EC/IRB submissions.
Strong knowledge of ICH-GCP, local regulations, and study start-up processes.
Experience with CTMS, eTMF, and clinical trial systems.
Strong project management, communication, and stakeholder management skills.
Fluent in English and Mandarin Chinese.
Please note: Position title will be determined based on the candidate's experience, skills, and overall qualifications.
#LI-Hybrid #LI-ST1
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
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
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