Designing, planning, coordinating, and conducting all activities involved in clinical research studies
Acting as primary contact and clinical trial expert for study site personnel
Performing site assessments and qualification visits to support site selection decisions
Developing and managing key study site documentation
Participating in and overseeing CRO delivery of site management activities
Validating product performance claims, supplying data for regulatory submissions
Executing site management activities for sponsored studies in assigned focus areas
Working with local and global study teams to achieve business goals

Requirements

Bachelor's degree in Science Degree preferably in Health Sciences or engineering (or equivalent combination of education and work experience)
3 years of working experience in 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 execution of clinical trials
Ability to make sound decisions and analyze and solve problems
Flexibility and adaptability to perform in a fast-paced, matrixed environment

Benefits

Discretionary annual bonus 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 managementregulatory submissionssite assessmentsstudy documentationclinical trial executiondata validationCRO managementIVD studiesmedical device studies

Soft Skills

decision makingproblem solvingflexibilityadaptabilitycommunicationcoordinationplanningleadershipinterpersonal skillsorganizational skills