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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D Product DevelopmentJob Sub Function:
R&D DigitalJob Category:
People LeaderAll Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of AmericaJob Description:
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Senior Manager, Clinical Trial Management Solutions (Trial Master File) in Horsham, PA, Spring House, PA, or Raritan, NJ.
Purpose:
The Senior Manager, Clinical Trial Management Solutions (Trial Master File) will provide operational & strategic leadership related to resource, budget, and portfolio management for Trial Master File (TMF) including ownership of the global TMF Business Process role. The Senior Manager will manage the interface between stakeholders, system, and processes, to ensure that the TMF/eTMF capabilities are aligned and effectively executing against identified organizational goals.
The Senior Manager provides input to operational plans with measurable contribution towards the achievement of department results for the Digital Research and Development (R&D) area. This position plays a critical role in the growth and development of the group and contributes to organizational effectiveness, transparency, and communication as a matrix leader driving projects, innovation, and capability growth or as a People Manager, through the recruitment, onboarding, performance management, and development of people while building an inclusive and diverse working environment.
Your will be responsible for:
- Leading high-impact technology projects to enhance site staff engagement, digital health, patient recruitment, study management/oversight and digital collaboration across clinical trials.
- Providing business leadership around system release planning and communication including ad-hoc configuration release strategies with IT partners and TMF Vendor
- Facilitating the introduction of new partners into the eTMF system including internal partners and external partners such as CROs, Investigators.
- Managing a high-functioning and diverse team to enable industry-leading, inspection-ready practices for supported capabilities, with a focus on delivering measurable value for stakeholders.
- Exploring internal and external trends to identify emerging technologies and potential opportunities to enhance clinical trial support systems through agile experimentation and design thinking.
- Maintaining a strategic focus on customer satisfaction, ensuring solutions are beneficial, meet regulatory compliance standards and are tailored to the needs of clinical study teams.
- Oversees the application of project management best practices, ensuring all technology implementations follow structured processes, from planning to training.
- Leading anticipation, early detection, prevention and management of risks and issues impacting departmental deliverables and activities.
- Leading knowledge-sharing efforts, fostering lessons learned across the department and with IT to improve system utilization and engagement strategies.
- Representing the department during System/Process audits and Sponsor Inspections for supported capabilities.
- May serve as Global Development Process Owner for specific capabilities
Qualifications / Requirements:
Education:
- Minimum of a Bachelor’s degree is required, preferably in Health, Science, Information Technology or another relevant field.
Required:
- 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
- The 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
Preferred:
- Project Management or Process Improvement certification
- Experience with Veeva Vault eTMF
- Experience leveraging Generative AI (GenAI) technologies to identify opportunities for process improvement, automation, and operational efficiency is preferred.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Skills Required
- Bachelor's degree, preferably in Health, Science, Information Technology, or a related field
- At least 8 years of relevant experience in clinical trial execution with a pharmaceutical, medical device company, or CRO
- Leadership experience in Trial Master File strategy, operations, and capability development
- Experience supporting regulatory inspections and maintaining TMF compliance with global regulations and industry standards
- Proficiency supporting clinical development IT systems, reporting tools, Office 365 applications, and database administration
- Understanding of the drug development process, Good Clinical Practices, and FDA Code of Federal Regulations
- Ability to partner with management and influence decisions across a matrix organization
- Superior communication, business partnering, problem-solving, and prioritization skills
- Project Management or Process Improvement certification
- Experience with Veeva Vault eTMF
- Experience using Generative AI for process improvement, automation, and operational efficiency
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
