Analyst II, Clinical Data Manager
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Overview
Job Description
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 jnj.com
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:
Data Analytics & Computational SciencesJob Sub Function:
Clinical Data ManagementJob Category:
ProfessionalAll Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, 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 an Analyst II, Clinical Data Manager in Titusville or Raritan, NJ.
Purpose: The Analyst II, Clinical Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML). Work is received in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited.
You will be responsible for:
- Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:
- Gather and/or review content and integration requirements for eCRF and other data collection tools.
- Establish conventions and quality expectations for clinical data.
- Establish expectations for dataset content and structure.
- Set timelines and follow-up regularly to monitor delivery of all data management milestones.
- Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
- Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
- Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
- Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
- Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
- Identify and participate in process, system, and tool improvement initiatives.
- Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities (e.g., Coding, SAE reconciliation) is possible.
- Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
Principal Relationships:
- Reports into people manager position within functional area (e.g., Data Management Leader).
- Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
- Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.
- External contacts include but not limited to: External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.
Qualifications/Requirements:
- Minimum of a Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
- Minimum of 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
- Experience in clinical drug development within the pharmaceutical industry or related industry.
- Experience working with cross functional stakeholders and teams.
- Strong written and verbal communications skills (in English).
Preferred
- Team leadership experience.
- Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
- In-depth knowledge of current clinical drug development processes.
- In-depth knowledge of applicable international guidelines regarding data management of clinical trials.
- Knowledge of technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange.
Other:
- Approx. required.
The expected pay range for this position is $92,000 to $148,350.
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)).
- 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
This job posting is anticipated to close on March 25, 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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Communication, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Organizing, Problem Solving, Report Writing, Standard Operating Procedure (SOP), Systems AnalysisThe anticipated base pay range for this position is :
$92,000.00 - $148,350.00Additional 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefitsAutomate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.