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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing global clinical trials from planning to execution, ensuring compliance with regulatory standards and maintaining inspection readiness. Proficient in stakeholder engagement, risk management, and cross-functional team leadership within the pharmaceutical industry.
Highest-signal resume keywords
Global Clinical Trial ManagementRegulatory SubmissionsEDC, IRT, CTMS, eTMF ProficiencyRisk Management and MitigationStakeholder Engagement
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 ManagementProtocol DevelopmentStudy Execution PlanningPatient-Reported Outcome MeasuresTrend Analysis
Soft Skills
Analytical ThinkingOrganizational SkillsAttention to DetailInterpersonal CommunicationCollaboration
Tools & Technologies
CTMSETMFEDCIRT
Industry Keywords
PharmaceuticalClinical ResearchSOPICH/GCPGlobal Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Plan, execute, and manage one or more Phase 0–4 global clinical trials
- Provide study-level oversight and leadership in a cross-functional environment from inception through closure
- Support strategic leadership of cross-functional teams through stakeholder engagement and influence
- Develop strategies, facilitate meetings, and maintain timely study-level documentation
- Manage external vendors, including RFPs, selection, scope of work, deliverables, and risk management
- Lead global recruitment strategy, feasibility, subject recruitment, retention, and mitigation planning
- Lead cross-functional, vendor, and investigator meetings; prepare agendas and curate and file minutes
- Ensure inspection readiness and participate in related activities
- Identify, mitigate, and manage risks, including issue review, escalation, and trend analysis
- Co-develop and manage protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent, site budgets and agreements, clinical study reports, training materials, newsletters, and presentations
- Manage CTMS and eTMF for compliance, inspection readiness, trend analysis, and timelines
- Support EDC, IRT, and ePRO design review, user acceptance testing, plan development, risk indicators, access, query resolution, and system oversight
- Manage investigational product and associated study supplies
- Provide stakeholder training
- Support global submission strategies
- Support process improvement initiatives or serve as a subject matter expert and/or mentor
Requirements
What you’ll need- Bachelor’s Degree or OUS equivalent required
- At least 4 years of progressive Pharma-related/clinical research-related experience
- High level of core and technical competencies
- Competent in standard quality procedures, including SOP, ICH/GCP, and Global Regulations
- Experienced user of EDC, IRT, CTMS, and eTMF
- Strong analytical and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- Exceptional interpersonal and communication skills in a global setting
- Proficient in business/technical English-language, oral and written
- Proactive, collaborative mindset
- Ability to work independently in a fast-paced global team environment
- Preferred: exposure to study initiation through completion activities and global study exposure
Benefits
Comp & perks- Equal opportunity employer
- Committed to operating with integrity, driving innovation, transforming lives and serving the community
