Manage the end-to-end start-up process for clinical research sites.
Act as a critical liaison between study teams, legal, privacy, CROs, and external sites.
Ensure all activities comply with global GCP, Global Standard procedures, and local regulatory requirements.
Perform site assessments and qualification visits to support the site selection decision process.
Develop and manage key study site documentation, such as Study Monitoring Plans, informed consent documents.
Validate product performance claims, supplying data for critical regulatory submissions.
Work in local and global study teams, fostering strong relationships with cross-functional team members.

Requirements

Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of education and work experience)
3 years of working experience in either the Medical Device or Diagnostics industry.
2 years of working experience in clinical study of IVD/Medical Device/Drug.
Excellent understanding of ICH GCP guidelines in the execution of clinical trials.

Benefits

Relocation benefits are not offered for this position.
A discretionary annual bonus may be available based on individual and Company performance.

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical researchsite assessmentsqualification visitsstudy site documentationStudy Monitoring Plansinformed consent documentsregulatory submissionsdata validationclinical trial executionGCP compliance

Soft Skills

liaisonrelationship buildingcross-functional collaborationcommunicationorganizational skillsteamworkproblem-solvingattention to detailadaptabilityleadership