Senior Manager, Clinical Trial Management Solutions – Trial Master File

Johnson & Johnson

Senior Manager leading Trial Master File strategy and eTMF systems for Johnson & Johnson’s clinical research organization. Managing technology projects, compliance, vendors, and clinical development teams.

Posted 8/20/2026full-timeHorsham • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $137,000 - $235,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Trial Master File (TMF) strategy and operations, ensuring compliance with regulatory standards while leading technology projects that enhance clinical trial processes. Proficient in stakeholder management and project management best practices to deliver measurable value and maintain customer satisfaction.

Highest-signal resume keywords

Trial Master File (TMF) StrategyRegulatory ComplianceProject ManagementVeeva Vault eTMFGenerative AI (GenAI) Technologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ExecutionBudget ManagementPortfolio ManagementDatabase AdministrationGood Clinical Practices (GCPs)FDA Code of Federal RegulationsDigital HealthStudy ManagementRisk ManagementAgile Experimentation

Soft Skills

LeadershipCommunicationProblem SolvingBusiness PartneringPrioritization

Tools & Technologies

Office 365 ApplicationsIT SystemsDigital Collaboration ToolsReporting Tools

Certifications & Qualifications

Project Management CertificationProcess Improvement Certification

Industry Keywords

Clinical Research Organization (CRO)PharmaceuticalMedical DeviceInspection-Ready PracticesStakeholder Value

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Provide operational and strategic leadership for resource, budget, and portfolio management for Trial Master File (TMF)
Own the global TMF Business Process role
Manage the interface between stakeholders, systems, and processes to align TMF/eTMF capabilities with organizational goals
Provide input to operational plans for the Digital Research and Development area
Lead high-impact technology projects enhancing site staff engagement, digital health, patient recruitment, study management/oversight, and digital collaboration across clinical trials
Provide business leadership for system release planning and communication with IT partners and the TMF vendor
Facilitate introduction of internal and external partners, including CROs and investigators, into the eTMF system
Manage a diverse team delivering inspection-ready practices and measurable stakeholder value
Explore trends and emerging technologies through agile experimentation and design thinking
Maintain customer satisfaction while ensuring regulatory compliance and clinical study team needs
Oversee project management best practices for technology implementations from planning through training
Lead anticipation, detection, prevention, and management of risks and issues affecting departmental deliverables
Lead knowledge-sharing and lessons-learned efforts with the department and IT
Represent the department during system/process audits and sponsor inspections
May serve as Global Development Process Owner for specific capabilities

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 8 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company, and/or a Clinical Research Organization (CRO)
Demonstrated track record of leadership in Trial Master File (TMF) strategy, operations, and capability development
Experience supporting regulatory inspections and ensuring TMF compliance in accordance with global regulatory requirements and industry standards
Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration
Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations
Ability to partner with all levels of management and influence decision making across a matrix organization
Superior communication, business partnering, problem solving, and prioritization skills
Project Management or Process Improvement certification preferred
Experience with Veeva Vault eTMF
Experience leveraging Generative AI (GenAI) technologies to identify opportunities for process improvement, automation, and operational efficiency preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 the 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and accommodation support