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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing international clinical studies, ensuring compliance with ICH-GCP guidelines, and supporting regulatory submissions. Proficient in eTMF management and maintaining essential study documentation while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
International Clinical Trials SupportETMF ManagementICH-GCP ComplianceStudy Start-Up ActivitiesMicrosoft Office Proficiency
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 Study DocumentationInvestigator Site Files ManagementRegulatory Submissions SupportStudy Feasibility ActivitiesSite Selection Processes
Soft Skills
Organizational SkillsCommunication SkillsTeam Collaboration
Certifications & Qualifications
ICH-GCP Certification
Industry Keywords
Clinical OperationsClinical Project ManagementClinical Research AssociatesStudy Activation ActivitiesMeeting Coordination
About the role
Key responsibilities & impact- Support the operational management of international clinical studies
- Work closely with Clinical Project Managers and CRA teams across multiple countries
- Manage Sponsor Trial Master Files (eTMF) and essential study documentation
- Support preparation, maintenance, and tracking of Investigator Site Files (ISF)
- Contribute to study feasibility activities and site selection processes
- Support submissions to regulatory authorities and ethics committees
- Assist with study start-up and site activation activities
- Provide operational support to Clinical Project Managers and Clinical Research Associates (CRAs)
- Organize study meetings, prepare agendas, participate in discussions, and draft meeting minutes
- Ensure clinical documentation is complete, accurate, and compliant with ICH-GCP requirements
- Collaborate with cross-functional teams across international clinical studies
- Provide back-up support for other clinical operations team members when required
Requirements
What you’ll need- Strong experience supporting international clinical trials
- Experience with eTMF management, Investigator Site Files (ISF), and clinical study documentation
- Good understanding of ICH-GCP guidelines; recent certification preferred
- Experience supporting study start-up, feasibility, and regulatory activities
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Fluent English (written and spoken)
Benefits
Comp & perks- Inclusive environment where collaboration and individual growth go hand in hand
- Diverse and stimulating projects
- Opportunities to collaborate with leading experts
- Environment that values natural talents, encourages boldness, pushes boundaries, and cultivates potential
- Opportunity to contribute to scientific, operational, and human knowledge
- Employee experience focus
- Work with a young and ambitious healthcare company and one-stop provider service model