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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in planning, executing, and monitoring clinical trials while ensuring compliance with regulatory requirements and prioritizing patient safety. Proficient in managing study documentation, participant recruitment, and training site personnel on protocols and compliance.
Highest-signal resume keywords
Clinical Trial ManagementICH-GCP CompliancePatient Safety MonitoringData Integrity AssuranceRegulatory Submissions Support
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 PlanningProtocol AdherenceRisk-Based MonitoringData Query ResolutionCRF VerificationETMF ManagementEDC FamiliarityCTMS FamiliarityMicrosoft Office ProficiencyPatient Recruitment Strategies
Soft Skills
Strong CommunicationOrganisational SkillsProblem-Solving AbilityTeam CollaborationIndependent Work Capability
Industry Keywords
Clinical ResearchLife SciencesNursingPharmacyRegulatory ComplianceStudy ProtocolsSerious Adverse EventsSite MonitoringParticipant RetentionStudy Close-Out Activities
About the role
Key responsibilities & impact- Plan, execute and monitor clinical trials from site initiation through close-out
- Ensure compliance with regulatory requirements, ICH-GCP and study protocols
- Prioritise patient safety, data integrity and timelines
- Assess potential sites based on capabilities, recruitment potential, staff experience and suitability
- Ensure studies are conducted according to protocols, ICH-GCP, regulations and company policies
- Verify CRFs, source documents and regulatory binders are accurate, complete and current
- Identify, document and report protocol deviations and ensure corrective and preventive actions
- Support participant recruitment and retention through screening and eligibility processes
- Monitor patient safety and ensure timely, accurate reporting of Serious Adverse Events
- Lead close-out activities and confirm completeness of study data and documentation
- Conduct on-site and remote monitoring visits, including pre-study, initiation, routine, accompanied and close-out visits
- Apply Risk-Based Monitoring principles to focus oversight on patient safety and data integrity
- Resolve data queries with site staff and Data Management
- Review and collect essential documents, support regulatory submissions and ensure accurate eTMF filing
- Train site personnel on protocols, compliance requirements and safety procedures
- Act as primary contact for study sites and collaborate with Project Managers and investigators
Requirements
What you’ll need- Degree in Life Sciences, Nursing, Pharmacy or a related field; equivalent experience in clinical research may also be considered
- Familiarity with clinical trial systems, including EDC, CTMS and eTMF
- Proficiency in Microsoft Office
- Strong communication, organisational and problem-solving skills
- Ability to work independently and effectively as part of a team
- Fluency in spoken and written English
- Additional languages are an advantage
Benefits
Comp & perks- Professional Career Framework with opportunities for career growth