(Senior) Study Start Up Associate
ICR United States USA
Apply to this jobICON 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
Summary
Support global clinical trials by managing study start-up, regulatory submissions, and site activation.
Job title
(Senior) Study Start Up Associate
Experience level
2+ years
Minimum experience
2+ years exp
Industry
healthcare
Location requirements
Taiwan, Taipei; hybrid work allowed
Salary
Not specified
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Taipei, Taiwan