Designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites
Acting as the primary contact and clinical trial expert for assigned study site personnel
Performing site assessments and qualification visits to support the site selection decision process
Developing and managing key study site documentation
Participating in and overseeing CRO delivery of site management activities
Validating product performance claims, supplying data for critical regulatory submissions
Executing site management activities for sponsored studies in assigned focus areas across all phases of study
Working in local and global study teams, including virtual teams

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

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 managementclinical trial executionregulatory submissionsdata validationstudy site documentationsite assessmentsqualification visitsCRO managementclinical diagnostics

Soft Skills

coordinationcommunicationteamworkleadershiporganizational skillsproblem-solvingattention to detailadaptabilityinterpersonal skillsproject management