Lead Site Coordinator

PSI CRO AG

. Provide day-to-day oversight and coordination for up to 8 Site Coordinators/Site Administrators .

Posted 11/9/2026full-timeRemote • TaiwanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in clinical trial oversight, compliance with ICH GCP, and effective communication with sponsors and CROs. Proficient in managing site operations, data integrity, and regulatory documentation.

Highest-signal resume keywords

Clinical Trial OversightICH GCP ComplianceData Management ProcessesSite CoordinationBudget Negotiation

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial ProceduresData Entry into EDC SystemsPatient Recruitment MonitoringRegulatory Document ManagementProcess Improvement Implementation

Soft Skills

CommunicationCollaborationTroubleshootingTraining

Tools & Technologies

MO1 CTMSECOA SystemsEPRO SystemsMS Office

Certifications & Qualifications

ICH GCP TrainingIATA Certification

Industry Keywords

Clinical ResearchSite AdministrationAdverse Events ReportingProtocol DeviationsInvestigator Payments

About the role

Key responsibilities & impact

Provide day-to-day oversight and coordination for up to 8 Site Coordinators/Site Administrators
Conduct trainings on clinical trial procedures
Conduct regular quality checks for compliance with ICH GCP, procedures, and regulations
Provide operational support, troubleshooting, and backup for site staff
Support identification of clinical research opportunities and relevant research networks
Collaborate on contract and budget negotiations
Oversee Investigator, Site, and MO1 payments
Review and ensure timely, accurate study-specific information entry into the MO1 CTMS
Monitor patient recruitment support and enrollment targets
Promote communication among site teams, Milestone One, sponsors/CROs, and medical institution staff
Prepare site teams for audits and inspections and provide on-site support
Propose and implement process improvements and operational tools
Act as the main communication line between Sponsor/CRO and the site
Respond to feasibility questions in due time
Schedule and prepare for monitoring visits and support monitors during visits
Track patient enrollment and support project timelines and enrollment goals
Maintain study-specific and general site document tracking
Enter data into study-specific EDC systems and resolve data clarification queries
Report and follow up on Adverse Events and Protocol Deviations
Handle, account for, and reconcile investigational products and clinical supplies
Collect and maintain site-specific regulatory documents
Facilitate site-level contract and budget negotiations
Support Investigator and Site payments
Schedule or perform study procedures according to study requirements and delegated responsibilities
Prepare for and participate in onsite audits or regulatory inspections
Build and sustain relationships with sponsors, CROs, and medical institutions

Requirements

What you’ll need

Please submit CV in English
University degree in life science, pharmacy, nursing, lab analytics or related (Master’s degree preferred)
ICH GCP training
IATA certification is an asset
Minimum 4 years of on-the-job experience in a clinical environment
Fluent use of local language
At least B2 level of English
Proficiency in MS Office
Valid category B driver’s license
Knowledge of the role and lifecycle of essential study documents in ensuring clinical trial compliance and data integrity
Understanding of clinical trial data management processes and the use of external vendor-supported systems
Knowledge of eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient-Reported Outcomes) systems