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Johnson & JohnsonPosted 10/19/2026full-timeRemote • New Jersey • United StatesSenior💰 $92,000 - $148,350 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with GCP, ICH, and local regulations, while effectively coordinating trial teams and maintaining quality data. Proficient in utilizing AI tools and technologies to enhance trial management and operational efficiency.
Highest-signal resume keywords
Clinical Trial ManagementGCP ComplianceAI LiteracyDrug Development ProcessSite Monitoring Experience
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Manage assigned clinical trials locally in one or more countries as the primary country-level contact
- Deliver quality data and trial documents compliant with protocols, GCP, healthcare compliance requirements, SOPs, and local regulations
- Provide operational oversight from study start-up through database lock and closeout
- Perform or support Trial Delivery Leader and Site Manager tasks for Early Development and Clinical Pharmacology studies
- Conduct study feasibility and site assessments and recommend suitable sites
- Coordinate local trial teams, recruitment planning, risk management, contingency planning, and budget forecasting
- Report and document SAEs, PQCs, and SUSARs within required timelines
- Maintain trial management systems and analyze trial progress using dashboards and reports
- Monitor study progress, initiate corrective and preventive actions, and escalate issues
- Support vendor services, vendor selection, invoices, site contracts, and budgets
- Set up and conduct investigator meetings and collaborate on site initiation visits
- Train and mentor Site Managers and Clinical Trial Assistants
- Review visit reports and support analytical risk-based monitoring
- Coordinate study supplies and ensure appropriate handling and storage of clinical drug supplies
- Monitor site recruitment and develop action plans for non-enrolling sites
- Prepare and manage master, country-specific, and site-specific informed consent forms
- Organize IEC/HA approvals and ensure regulatory compliance
- Support CAPA development and implementation for audits, inspections, and quality visits
- Act as protocol expert and primary local GCO contact
- Build relationships with investigators, trial coordinators, site staff, and internal stakeholders
- Contribute to process improvement initiatives and conduct accompanied site visits
- Assume additional champion or subject matter expert responsibilities as assigned
Requirements
What you’ll need- A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required
- Minimum of 2 years of clinical trial management experience, in addition to site monitoring experience, is preferred
- Previous clinical trial experience in ED&CP is preferred
- Demonstrated AI literacy and an AI-enabled mindset
- Ability to apply AI tools responsibly in daily work
- Solid understanding of the drug development process, including ICH/GCP and local regulatory requirements
- Proficient in speaking and writing the country language and English language
- Good written and oral communication skills
- Strong IT skills in appropriate software and company systems
- Willingness to travel with occasional/regular overnight stays away from home
- Ability to work at a fast pace within small exploratory international study teams
- Ability to work on multiple trials in parallel in different disease areas
Benefits
Comp & perks- Retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and disability accommodations
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial ManagementSite MonitoringData AnalysisRisk ManagementBudget ForecastingRegulatory ComplianceFeasibility AssessmentInformed Consent PreparationCAPA DevelopmentTrial Documentation
Soft Skills
Communication SkillsTeam CollaborationMentoringRelationship BuildingProblem Solving
Tools & Technologies
Trial Management SystemsDashboardsAI ToolsClinical Drug Supplies ManagementVendor Management Software
Industry Keywords
Clinical TrialsEarly DevelopmentClinical PharmacologyHealthcare ComplianceSOPsIEC/HA ApprovalsSAEsPQCSUSARsInternational Study Teams