(Senior) Site Specialist role at ICON Taiwan. Lead site activation, regulatory submissions & CDP management. Hybrid office role. Exp in Taiwan/APAC clinical start-up, ICH-GCP & local regulations req. #StudyStartUp #SiteActivation #ClinicalOperations #Taiwan #Hybrid #ICONplc
Lead Clinical Study Start-Up and Accelerate Site Activation in Taiwan
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are seeking an experienced (Senior) Site Specialist to join our Site & Study Activation (SSUA) team in Taiwan. In this senior hybrid role, you will be the driving force behind the activation of clinical trial sites, expertly navigating local regulatory requirements, managing critical documents, and leading coordination efforts to ensure studies start on time. You will serve as an internal consultant, mentor junior staff, and be the primary point of contact for high-volume or complex study programs. If you are a detail-oriented leader passionate about optimizing processes to bring new therapies to patients faster, we invite you to apply.
Your Mission: Expertly Navigate Site Activation from Plan to Execution
You will own the site activation timeline and deliverables, ensuring all regulatory and ethical submissions are complete, accurate, and compliant.
Key Responsibilities:
1. Strategic Site Activation Leadership
- Act as the primary point of contact and coordinator for site activation activities on high-volume studies or study programs.
- Serve as an internal consultant to optimize site activation workflows, tool setup, and best practices.
- Support the training and onboarding of more junior Site Activation Specialists.
- Accurately forecast site activation plans, ensure accurate system reflection, and proactively follow through to achieve milestones.
2. Regulatory & Document Mastery
- Proficiently drive the collection, review, and assembly of all regulatory submission packages for Central/Local EC/IRB and Competent Authorities (TFDA) in full compliance with ICH/GCP and Taiwanese regulations.
- Manage the Critical Document Package (CDP), ensuring accuracy, completeness, and that all Sponsor/Investigator obligations are met.
- Coordinate necessary translations for start-up documentation.
- Ensure Trial Master File (TMF) readiness by performing QC reviews on all start-up documents before filing.
3. Process Excellence & Collaboration
- Set up and manage internal tracking tools to enable effective progress monitoring against site activation requirements.
- Perform timely and accurate data entry of all site activation activities into tracking systems (e.g., CTMS).
- Participate in internal study review meetings to identify site activation risks and contribute to mitigation and action planning.
- Collaborate with Site Partners and internal stakeholders (Clinical, Regulatory) to optimize study performance and drive successful project outcomes.
Who You Are: The Expert in Clinical Start-Up
You are a seasoned professional with a deep understanding of the clinical start-up landscape in Taiwan and a proven ability to lead and execute.
Your Profile:
- Recognizes and exemplifies ICON’s values of Accountability, Collaboration, Partnership, and Integrity.
- Proficient knowledge of ICON SOPs, ICH/GCP, and applicable Taiwanese regulatory guidelines.
- Several years of hands-on experience in clinical study start-up, site activation, or regulatory submissions within Taiwan. Experience with TFDA submissions is essential.
- Proven experience acting as a coordinator or lead on complex or high-volume studies.
- Strong leadership skills with experience in mentoring or training junior staff.
- Exceptional organizational skills, attention to detail, and the ability to manage multiple competing priorities.
- Excellent communication and stakeholder management skills in both English and Mandarin.
- Proactive, solutions-oriented mindset with a commitment to process improvement.
What ICON Can Offer You:
Our success depends on the quality of our people. We offer a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, ICON offers a range of benefits in Taiwan focused on well-being:
- Hybrid office work model for flexibility.
- Various annual leave entitlements.
- Comprehensive health insurance for you and your family.
- Competitive retirement planning.
- Global Employee Assistance Programme offering 24/7 support.
- Life assurance.
- Flexible, country-specific optional benefits.
Visit our careers site to learn more.
Our Commitment to You
At ICON, inclusion & belonging are fundamental. We are an equal opportunity employer dedicated to providing an inclusive, accessible environment.
If you require a reasonable accommodation during the application process, please let us know.
Interested but unsure if you meet all requirements? We encourage you to apply regardless.
Ready to Be the Architect of Efficient Study Start-Up in Taiwan?
If you are a senior site activation specialist ready to take on a leadership role with a global CRO, we encourage you to apply.
Apply now for the (Senior) Site Specialist position in Taiwan.
