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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 compliance with ICH/GCP and Global Regulations, while effectively supporting cross-functional teams and managing study-related documentation. Proficient in generating training and resolving study-related issues to ensure successful study execution.
Highest-signal resume keywords
Clinical Trial ManagementICH/GCP ComplianceStudy Protocol DevelopmentVendor ManagementFluent in English (C1)
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 ExecutionStudy Blueprint DevelopmentECRF ManagementInformed Consent Form PreparationCTMS MaintenanceStudy Status ReportingProcess Improvement InitiativesStandard Operating Procedures ApplicationClinical Research ExperiencePharma-Related Experience
Soft Skills
Good Communication SkillsProblem SolvingTeam CollaborationProactive Issue Resolution
Tools & Technologies
CTMSIRT
Certifications & Qualifications
Registered Nurse Licensure
Industry Keywords
Clinical ResearchPharmaceuticalsEthics and ComplianceStudy InitiationStudy Completion
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Execute one or more elements of clinical studies in compliance with ICH/GCP, Global Regulations, and AbbVie policies and procedures
- Support the Study Project Manager in leading the cross-functional study team
- Support preparation of clinical study team meetings, including agendas and minutes
- Provide regular study-status updates to the cross-functional team and stakeholders
- Keep the CTMS up to date
- Support development of clinical study blueprints, protocols, and associated systems and documents, including informed consent forms, eCRFs, IRT, and CSR
- Support vendor selection, scope development, management, and oversight
- Generate study-related training for study teams, study sites, and vendors
- Proactively identify, resolve, and/or escalate study-related issues
- Participate in process improvement initiatives
Requirements
What you’ll need- Bachelor’s Degree or OUS equivalent degree, typically in nursing or scientific field
- Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable
- At least four years of pharma-related or clinical research-related experience
- Demonstrated high level of core and technical competencies
- Good communication skills
- Competence in applying standard business procedures, including standard operating procedures, ICH, Global Regulations, Ethics and Compliance
- Preferred exposure to study initiation through study completion
- At least 3 years in clinical trial management positions
- Fluent in English (C1)
- Must be located in Madrid
Benefits
Comp & perks- Remote work option
- Equal opportunity employment
- Commitment to operating with integrity, driving innovation, transforming lives, and serving the community
