Site Specialist II

ICON plc • Contract • Osaka, Japan • 2w ago

Site Specialist II role at ICON Japan (Tokyo/Osaka). Manage study site activation, regulatory submissions & critical documents for clinical trials. 3-6 yrs exp in clinical start-up in Japan required. Bilingual (Japanese/English). #ClinicalResearch #SiteActivation #StudyStartUp #TokyoJobs #OsakaJobs #Japan #CRO

Accelerate Clinical Trial Start-Up in Japan

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.

Role Summary:

We are seeking a meticulous and proactive Site Specialist II to be based in Tokyo or Osaka, Japan. In this pivotal role, you will support the preparation, processing, and tracking of all regulatory and site-level documents essential for successful study site activation. You will ensure compliance with ICON and sponsor SOPs, ICH/GCP, and local Japanese regulations, acting as a key driver in bringing new clinical trials to patients. If you are detail-oriented and passionate about optimizing processes to accelerate clinical development, we invite you to apply.

Your Mission: Drive Efficient and Compliant Site Activation

You will be the operational expert ensuring all documentation and regulatory requirements are met for site activation, collaborating closely with Site Partners and internal teams.

Responsibilities:

Regulatory & Document Mastery: Support Site Partners by proficiently collecting, reviewing, and assembling regulatory submission packages for Central/Local EC/IRB, PMDA, and other Japanese authorities in compliance with ICH/GCP.
Critical Document Package (CDP) Management: Ensure the accuracy and completeness of the CDP for site activation, verifying Sponsor and Investigator obligations are met.
Process Coordination & Tracking: Coordinate necessary document translations and perform timely, accurate data entry of site activation activities into tracking systems (e.g., CTMS).
Planning & Forecasting: Accurately forecast site activation plans in ICON’s systems and proactively follow through to achieve milestones.
Risk Management & Quality: Contribute to study review meetings to identify site activation risks and support mitigation planning. Perform QC review of Trial Master File (TMF) documents.
Stakeholder Collaboration: Work effectively with Site Partners and internal stakeholders (Clinical, Regulatory) to optimize study performance and ensure successful project outcomes.

Who You Are: The Ideal Candidate

You are an organized professional with a solid foundation in clinical research operations, particularly in the critical start-up phase within Japan.

What You Need:

Bachelor’s Degree.
3-6 years of experience in a Clinical Research environment, with direct hands-on experience in study start-up, site activation, and/or regulatory submissions within Japan.
Fluency in both Japanese and English (written and verbal) is essential for document handling and stakeholder communication.
Demonstrated organizational skills with the ability to prioritize tasks and manage competing deadlines.
Good computer literacy and proficiency in Microsoft Office.
Ability to work independently and efficiently to complete tasks on time.
Strong collaboration skills and the ability to identify, document, and help mitigate study risks.
Experience with clinical trial management systems (CTMS) and document tracking tools is preferred.

応募資格: