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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, including oversight of study materials, compliance, and risk management. Proficient in stakeholder engagement and cross-functional team leadership, with strong analytical and organizational skills.
Highest-signal resume keywords
Global Clinical Trial ManagementEDC, IRT, CTMS, eTMF ProficiencyRisk Management and MitigationStakeholder Engagement and CommunicationRegulatory Compliance and Quality Procedures
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 ManagementStudy Protocol DevelopmentRegulatory SubmissionsRisk AnalysisTrend AnalysisStudy Execution PlanningPatient-Reported Outcome MeasuresInvestigational Product ManagementVendor ManagementMeeting Facilitation
Soft Skills
Analytical ThinkingOrganizational SkillsAttention to DetailInterpersonal SkillsCollaboration
Industry Keywords
PharmaceuticalClinical ResearchSOPICH/GCPGlobal RegulationsStudy InitiationStudy CompletionInspection ReadinessSubject RecruitmentProcess Improvement
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide study-level oversight and leadership for one or more global clinical trials from inception through closure
- Support the Study Project Manager in strategic leadership of cross-functional teams, stakeholder engagement, strategy development, meeting facilitation, documentation, deliverables, and timelines
- Manage external vendors, including RFPs, selection, scope of work, deliverable oversight, and risk management
- Lead global recruitment management, strategy development, and mitigation planning from country feasibility through subject recruitment and retention
- Lead cross-functional, vendor, and investigator meetings; prepare agendas, curate and file minutes, and provide study-status updates
- Ensure inspection readiness and participate in related activities
- Identify, mitigate, escalate, and manage risks and issues; support trend analysis and risk prevention
- Co-develop and manage study materials, including protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent, site budgets and agreements, clinical study reports, training materials, newsletters, and stakeholder presentations
- Manage CTMS and eTMF to support compliance, inspection readiness, trend analysis, and timelines
- Support EDC, IRT, and ePRO design reviews, user acceptance testing, plans, key risk indicators, access support, query resolution, and system oversight
- Manage investigational product and associated study supplies
- Provide training to study team members, vendors, and other stakeholders
- 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 with a high level of core and technical competencies
- Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
- Experienced user of EDC, IRT, CTMS, and eTMF
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and develop strategies
- Excellent organizational and time management skills; strong attention to detail
- Exceptional interpersonal skills and ability to communicate effectively in a clear and persuasive manner 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; global study exposure
