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PSI CRO AG

Operations Manager, Clinical Research

PSI CRO AG

. Oversee the operational conduct of clinical trials at contracted medical institutions within a defined country or region .

Posted 11/9/2026full-timeRemote • TaiwanMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

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

Demonstrates expertise in overseeing clinical trial operations, ensuring compliance with ICH GCP and regulatory requirements while fostering a culture of accountability and continuous improvement. Proficient in managing teams and driving process standardization to enhance operational efficiency.

Highest-signal resume keywords
Clinical Trial Operations ManagementICH GCP ComplianceTeam LeadershipBudget NegotiationClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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

Hard Skills
Clinical Research ActivitiesOperational Guidelines DevelopmentProcess ImprovementStudy Activation Timelines ManagementFeasibility Assessment
Soft Skills
Excellent Communication SkillsEffective Problem SolvingAccountable LeadershipResult OrientedManagement Skills
Tools & Technologies
MS OfficeSite TrackersStudy ReportsTimesheets
Certifications & Qualifications
ICH GCP TrainingBusiness Management Certification
Industry Keywords
Clinical TrialsLife SciencesResearch ProtocolsRemote Staff ManagementOperational Conduct

About the role

Key responsibilities & impact
  • Oversee the operational conduct of clinical trials at contracted medical institutions within a defined country or region
  • Provide leadership to Lead Site Coordinators and Site Coordinators as a subject matter expert and escalation point for operational issues
  • Assess feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials
  • Monitor budget negotiations and study activation timelines to support timely site readiness
  • Manage Study Coordinators and oversee the quality and results of their work through study reports, timesheets, site trackers, and other operational tools
  • Drive process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, and controlled documents
  • Contribute to operational guidelines, templates, and procedures
  • Create a work culture promoting process transparency, accountability, and continuous learning

Requirements

What you’ll need
  • Associate degree in life sciences or similiar
  • Business Management degree or certification is a plus
  • ICH GCP Training
  • Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred
  • Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out
  • Fluent use of English
  • Proficiency in MS Office
  • Valid category B driver’s license
  • Excellent communications skills
  • Excellent management skills, experience managing remote staff preferred
  • Effective problem solving and result oriented
  • Accountable Team leadership skills