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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 management, including site monitoring, patient safety, and compliance with ICH/GCP and FDA regulations. Proficient in managing investigator site relationships and facilitating effective communication among study teams and vendors.
Highest-signal resume keywords
Clinical Trial MonitoringICH/GCP ComplianceSite Activation ManagementAdverse Event MonitoringBachelor's Degree in Life Sciences
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 MethodologiesSite MonitoringProtocol SupportData Query ResolutionTMF DocumentationQuality Event RemediationCorrective and Preventive ActionsOnsite MonitoringRemote MonitoringPatient Safety Management
Soft Skills
CoachingTrainingCommunicationProblem-SolvingRelationship Management
Certifications & Qualifications
Valid Driver's LicensePassport
Industry Keywords
Clinical ResearchFDA RegulationsLocal Country RegulationsInvestigational Product ManagementStudy Progress Updates
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage, monitor and close out assigned clinical trial investigator sites
- Ensure patient safety and quality study execution in accordance with applicable laws, GCP and sponsor standards
- Manage investigator site relationships and operational aspects from site activation through database lock
- Serve as primary point of contact for assigned investigator sites
- Facilitate information flow among study team members, vendors and investigator sites
- Provide site personnel coaching, training and protocol support
- Support site activation, recruitment initiatives and enrollment
- Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure
- Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
- Submit required TMF documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress updates
- Identify and resolve site issues and develop corrective and preventive actions
- Resolve data queries and conduct investigator site close-out activities
- Oversee investigational product receipt, handling, accounting, storage and destruction
- Support database release and unblinded monitoring where appropriate
- Maintain product, protocol and therapy-area knowledge
- Support patient safety, eligibility and clinical guidance
- Drive Quality Event remediation and audit CAPA activities when applicable
Requirements
What you’ll need- Minimum 2 years relevant experience in clinical research site monitoring
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
- Fluency in English and the native language(s) of the country they will work in
- Ability to travel 60-80%
- Valid driver’s license and passport required
- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Benefits
Comp & perks- Equal opportunity employment
- Travel allowance implied by required travel (no explicit benefit stated)