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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Contributes to the selection of potential investigators.
- Responsible for study start-up and regulatory maintenance, including submissions to EC/IRB and Regulatory Authorities.
- Trains and advises investigators and site staff in study related matters.
- Ensures sites are inspection ready and maintains regular communication with study teams.
- Initiates, monitors and closes study sites as per compliance.
- Conducts monitoring visits, remote data checks, and Quality Risk Assessments during the study.
- Ensures accurate and timely reporting of Serious Adverse Events.
Requirements
What you’ll need- Excellent attention to detail.
- Good written and verbal communication skills.
- Good collaboration and interpersonal skills.
- Good negotiation skills.
- Proficient in written and spoken English language required.
- Fluency in local language(s) required.
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Familiar with risk-based monitoring approach including remote monitoring.
- Good cultural awareness.
- Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs).
Benefits
Comp & perks- Ability to travel nationally/internationally as required
- Valid driving license per country requirements, as applicable
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
monitoringregulatory maintenancedata managementQuality Risk Assessmentsstudy start-upSerious Adverse Events reportingdrug development processrisk-based monitoringstudy drug handlingclinical study management
Soft Skills
attention to detailwritten communicationverbal communicationcollaborationinterpersonal skillsnegotiation skillscultural awarenessability to learntrainingadvising
Certifications
Bachelor's degree in life science
