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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial methodologies, ICH/GCP, and FDA regulations, with a strong focus on site monitoring and quality assurance in clinical research. Proficient in managing investigator site relationships and ensuring compliance with Good Clinical Practices.
Highest-signal resume keywords
Clinical Trial MethodologiesICH/GCP ComplianceSite MonitoringOncology ExperienceFluency in English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MonitoringAdverse Event MonitoringRegulatory ReportingDocumentation ManagementQuality Assurance
Soft Skills
Problem SolvingCollaborationCommunication
Industry Keywords
Good Clinical PracticesFDA RegulationsOncologyVaccinesInternal MedicineInfectious Diseases
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensure proper conduct of clinical trials in accordance with applicable laws, Good Clinical Practices, and Pfizer standards
- Serve as the primary point of contact for assigned investigator sites
- Conduct onsite, remote/electronic monitoring as needed for study site activities
- Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit
- Submit all required reports, documentation, updates within required timeframes
- Identify and resolve investigator site issues within required timeframes
- Ensure quality of site delivery
Requirements
What you’ll need- Bachelor’s degree in life sciences or professional degree in life sciences
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
- Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- Must be fluent in English and in the native language(s) of the country they will work in
Benefits
Comp & perks- remote work options
