At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job 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 Standards Management Expert CRF) within Integrated Data Analytics & Reporting (IDAR), to contribute to the Clinical Data Standards team as a leading expert individual contributor, guiding the execution of projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy.

Purpose:

The Standards Management Expert (CRF) applies comprehensive knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

The role may be located in Titusville, NJ / Raritan, NJ /Spring House, PA, US.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-046105

United Kingdom -Requisition Number: R-048175

Belgium/Netherlands/India - Requisition Number: R-048177

Switzerland - Requisition Number: R-048179

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

You will be responsible for:

Senior Manager / Associate Director Standards Management Expert (CRF) is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, review, delivery and analysis & reporting, aligned with protocol and medical writing requirements. Examples of standard content:

• Standard case report forms, including validation rules and integrations (e.g., JEISR, IxRS)
• Standard questionnaires, rating scales, and clinical outcome assessments
• Supportive documentation to guide and support the adoption of standards in clinical trials.

The role is responsible for acquiring and maintaining deep expertise in the various data collection, review and analysis tools and templates applied in the clinical trials, specifically those in use in J&J (e.g., Rave eDC, Stds4U), in industry standards, including but not limited to CDISC standards (SDTM, CDASH, Controlled Terminology, and define.xml) and adjacent data standards (e.g., HL7 / FHIR, OHDSI/OMOP).

The role should be knowledgeable in using common clinical data tools such as Medidata Rave, LSAF, Pinnacle 21, or SAS. The position may also be involved in innovative projects requiring the learning of new tools and standards.

The role is responsible for remaining aware of the industry standards development and trends, and regulatory requirements, to support the development strategy and evolution of the J&J standards accordingly.

The position will maintain oversight of ongoing standards development work and projects they are accountable for. The position will give specific attention to the fit with the CDS standards strategy, interdependences between projects, prioritization of projects, and standards development work in CDS while assessing the organizational readiness in CDS and the IDAR functions to implement the solutions in an optimal way in the clinical studies.

Principal Relationships:

Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Clinical Data Standards and others as needed.

External: Interact and collaborate with vendors. Act as J&J representative for defining process standards and sharing best practices with industry counterparts and working groups, as required.

Education and Experience Requirements:

• A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD)
• At least 8 years of relevant pharmaceutical/scientific experience in a related discipline, e.g., data management, biostatistics, clinical or statistical programming
• Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM)
• Demonstrated written and verbal communications skills
• Demonstrated customer focus and solution-oriented experience
• Demonstrated interpersonal skills to build relationships with internal and external business partners
• Demonstrated leadership on cross-functional projects
• Demonstrated leadership in decision making and problem solving
• Excellent spoken and written English

For United States applicants only:

The expected base pay range for this position in the US is $137,000 to $235,750 (USD).

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.

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)).

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 period 10 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

This job posting is anticipated to close on January 5, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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:

Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Issue Escalation, Learning Management Systems (LMS), Leverages Information, Organizing, Program Management, Regulatory Affairs Management, Research Ethics, Technical Credibility

 

 

The anticipated base pay range for this position is :

$137,000 to $235,750 (USD)

Additional Description for Pay Transparency:

The expected base pay range for this position in the US is $137,000 to $235,750 (USD). The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. 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)). 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 period 10 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 (https://www.careers.jnj.com/employee-benefits) This job posting is anticipated to close on January 5, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com (https://www.careers.jnj.com) to accept additional applications.