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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 protocol development, regulatory submissions, and vendor management. Proficient in ensuring compliance with ICH/GCP standards and maintaining inspection readiness throughout the study lifecycle.
Highest-signal resume keywords
Clinical Trial ManagementRegulatory SubmissionsVendor ManagementRisk ManagementEDC/IRT/CTMS/eTMF Experience
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 DevelopmentRegulatory ComplianceRisk ManagementStudy Execution PlanningData AnalysisSOPsQuality ProceduresRecruitment StrategiesInspection Readiness
Soft Skills
Analytical ThinkingOrganizational SkillsAttention to DetailInterpersonal CommunicationCollaboration
Tools & Technologies
EDCIRTCTMSETMF
Industry Keywords
Clinical ResearchPharmaceuticalDeviceICHGCPGlobal Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Contribute to the planning, execution, and management of one or more Phase 0–4 global clinical trials
- Support the Study Project Manager and cross-functional team with stakeholder engagement, meeting facilitation, documentation, deliverables, and timelines
- Manage external vendors, including RFPs, vendor selection, scopes of work, deliverables, and risk management
- Manage recruitment strategies and mitigation planning from country feasibility through subject recruitment and retention
- Lead cross-functional, vendor, and investigator meetings and provide regular study-status updates
- Ensure inspection readiness and participate in related activities
- Identify, mitigate, escalate, and manage study risks
- Co-develop and manage protocols, regulatory submissions, 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 reviews, user acceptance testing, plans, risk indicators, access support, query resolution, and system oversight
- Manage investigational product and associated study supplies
- Provide training to study teams, vendors, and other stakeholders
- Support process improvement initiatives or serve as a subject matter expert or mentor
Requirements
What you’ll need- Bachelor's Degree or OUS equivalent required
- At least 2 years of pharma/device or clinical research related experience
- Competency in standard quality procedures, SOPs, ICH/GCP, and Global Regulations
- Analytical and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- Strong interpersonal and persuasive communication skills
- Proficient in business/technical English, oral and written
- Proactive, collaborative mindset
- Ability to work independently in a fast-paced global team environment
- Preferred: experience with one or more clinical trial systems, such as EDC, IRT, CTMS, or eTMF
- Preferred: experience in one or more parts of a clinical trial
Benefits
Comp & perks- Paid time off including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive programs
- Remote/virtual work option
- Equal opportunity employer; veterans and disabled applicants supported
