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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations while managing investigator sites and ensuring compliance with study protocols. Capable of facilitating communication among study teams and providing training to site personnel to support patient safety and trial integrity.
Highest-signal resume keywords
Clinical Trial MonitoringICH/GCP ComplianceOncology ExperienceSite ManagementPatient Safety
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 MethodologiesDatabase Lock ProceduresAdverse Event MonitoringProtocol TrainingSite Activation SupportTrial Master File DocumentationData Query ResolutionInvestigational Product HandlingCAPA DevelopmentRemote Monitoring
Soft Skills
CoachingCommunicationProblem-SolvingCollaborationTraining
Certifications & Qualifications
Bachelor’s Degree in Life SciencesValid Driver’s LicensePassport
Industry Keywords
Good Clinical PracticesFDA RegulationsOncologyVaccinesInternal MedicineInfectious DiseasesGlobal Clinical TrialsSite InitiationStudy Monitoring PlanPatient Eligibility
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage and monitor assigned investigator sites from site initiation through database lock and close-out
- Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards
- Serve as primary contact for assigned investigator sites during study conduct
- Facilitate information flow among study team members, vendors and investigator sites
- Coach and train site personnel and provide protocol training
- Support enrollment and resolve site activation and recruitment issues
- Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure
- Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
- Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress updates
- Identify and resolve site issues and develop corrective and preventative actions
- Resolve data queries and conduct investigator site close-out activities
- Oversee investigational product receipt, handling, accounting, storage and destruction
- Support database release and undertake unblinded monitor responsibilities when required
- Maintain knowledge of the product, protocol and therapy area
- Support patient safety, eligibility and clinical guidance for investigators
- Drive Quality Event remediation and audit observation CAPA development when applicable
Requirements
What you’ll need- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
- Minimum 3 years of relevant experience in clinical research site monitoring
- Preferably 2 years in Oncology
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- Global clinical trial experience
- Fluent in English and the native language(s) of the country they will work in
- Valid driver’s license and passport required
- Significant travel (60–80%) within area required
- May require international and weekend travel
Benefits
Comp & perks- Flexible workplace culture supporting work-life harmony
- Reasonable adjustments for disability inclusion
- Equal employment opportunities
- Significant travel within the area and possible international travel
