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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 from start-up to closeout, ensuring compliance with GCP, ICH guidelines, and local regulations. Proficient in trial management, vendor coordination, and maintaining relationships with stakeholders while supporting process improvements.
Highest-signal resume keywords
Clinical Trial ManagementGCP ComplianceSite Monitoring ExperienceAI LiteracyDrug Development Process Knowledge
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Manage assigned clinical trials locally from start-up through database lock and closeout
- Serve as the primary local point of contact for assigned trials
- Perform Local Trial Manager tasks and potentially Trial Delivery Leader and Site Manager tasks
- Conduct study feasibility and site assessments and recommend suitable sites
- Coordinate pre-trial activities and collaborate on final site selection
- Develop country-level study management documents, procedures, tools, recruitment plans, risk management, and budget forecasts
- Lead local trial teams and coordinate activities in compliance with GCO SOPs, GCP, HCC, regulations, and protocols
- Ensure timely reporting and documentation of SAEs, PQCs, and SUSARs
- Maintain trial management systems and analyze progress reports and dashboards
- Monitor study progress, initiate corrective and preventive actions, and escalate issues
- Support vendor services, vendor selection, invoices, site contracts, and budgets
- Manage forecasts, finance reporting, and delivery within budget
- Set up and conduct Investigator Meetings and collaborate on site initiation visits
- Conduct trial team meetings and facilitate Site Manager training
- Review Visit Reports and support analytical risk-based monitoring
- Support data-entry action plans and monitor site recruitment
- Coordinate study supplies and ensure proper handling and storage of clinical drug supplies
- Prepare and manage master, country-specific, and site-specific informed consent forms
- Organize IEC/HA approvals and ensure local regulatory compliance
- Ensure CAPAs are developed and implemented for audits, inspections, and quality visits
- Act as protocol expert and develop therapeutic-area and early-development knowledge
- Maintain relationships with investigators, site staff, and internal stakeholders
- Contribute to process improvement, training, and mentoring of Site Managers and Clinical Trial Assistants
- Conduct accompanied site visits and assume 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; other relevant experiences and skills may be considered
- Previous clinical trial experience in ED&CP is preferred
- Demonstrated AI literacy and an AI-enabled mindset, including responsible application of AI tools
- Specific therapeutic area experience/knowledge may be required
- 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
- Strong IT skills in appropriate software and company systems
- Willingness to travel with occasional/regular overnight stays
- 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 AssessmentRisk ManagementBudget ForecastingData AnalysisInformed Consent PreparationRegulatory ComplianceSAE ReportingPQC DocumentationCAPA Development
Soft Skills
Team LeadershipCommunicationCollaborationProblem-SolvingMentoring
Tools & Technologies
Trial Management SystemsStudy Management DocumentsRecruitment PlansAnalytical Monitoring ToolsVendor Management Software
Industry Keywords
Life SciencesClinical TrialsED&CPICH GuidelinesLocal Regulatory RequirementsInvestigator MeetingsSite ContractsClinical Drug SuppliesIEC/HA ApprovalsTherapeutic Area Knowledge