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Senior Engineer, R&D Digital
Johnson & Johnson. Execute plans and processes for Clinical Trial Management Solutions (CTM Solutions) systems and processes .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Management Solutions (CTM Solutions) with a strong focus on optimizing systems and processes, supporting clinical trial execution, and ensuring compliance with Good Clinical Practices (GCPs) and FDA regulations. Proficient in IT systems support, project management, and effective communication across cross-functional teams.
Highest-signal resume keywords
Clinical Trial Management Solutions (CTM Solutions)Good Clinical Practices (GCPs)Project Management CertificationIT Systems SupportClinical Trial Execution
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 ExecutionDatabase AdministrationProcess ImprovementWorkflow AutomationAnalyticsUser Acceptance TestingSystem TroubleshootingTraining DevelopmentRegulatory ComplianceStudy Lifecycle Management
Soft Skills
CommunicationProblem SolvingBusiness PartneringPrioritizationInfluencing
Tools & Technologies
CTMSOffice 365 ApplicationsService Ticket SystemsGenAI Capabilities
Certifications & Qualifications
Project Management CertificationProcess Improvement Certification
Industry Keywords
PharmaceuticalMedical DeviceClinical Research Organization (CRO)FDA Code of Federal RegulationsGlobal Business Mindset
About the role
Key responsibilities & impact- Execute plans and processes for Clinical Trial Management Solutions (CTM Solutions) systems and processes
- Support clinical trial study management and oversight solutions including CTMS, Site Payments, and Access Provisioning
- Identify and implement technology improvements that optimize CTM Solutions systems and processes and deliver measurable value
- Assess study-team needs and translate them into practical system and process solutions
- Support study build, maintenance, and effective system use throughout the study lifecycle
- Provide end-user support through service tickets and shared mailboxes
- Identify and support workflow improvements through automation, analytics, and GenAI capabilities
- Coordinate release management, user acceptance testing, system improvements, and integrations with IT, system owners, and suppliers
- Troubleshoot advanced system and process issues with IT and vendors
- Create and deliver training, guidance, and reference materials
- Facilitate team meetings and contribute to cross-functional projects
- Support system and process audits, regulatory inspections, and corrective and preventive actions
- Serve as a liaison between the business community and key partners and stakeholders
Requirements
What you’ll need- Minimum of a Bachelor’s degree is required, preferably in Health, Science, Information Technology or another relevant field
- Minimum of 5 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required
- Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required
- Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations is required
- Ability to partner and influence people at all levels of the organization
- Superior communication, business partnering, problem solving, and prioritization skills
- Global business mindset
- Ability to travel up to 10% of the time (Domestic/International)
- Project Management or Process Improvement certification is preferred
Benefits
Comp & perks- Annual bonus with set target (% of pay) depending on pay grade / location
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs for financial, physical and mental health
- Service anniversary and recognition awards
- Several insurance plans for employees and, in some locations, eligible dependents
- Netherlands annual base pay includes an 8% holiday allowance