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:
Johnson & Johnson Innovative Medicine R&D is recruiting for an Analyst II, Clinical Data Manager. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.
The Analyst II, Clinical Data Manager is a professional individual contributor role at the junior level that will provide oversight and accountability and/or execute data management activities and/or perform scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. This individual will make recommendations and influence decisions for specific trials or assignments. Analyze and provide input into decisions with direction from manager or
Data Management Leader (DML). The work is received in broad terms and is reviewed on an ongoing
basis with the DML and the amount of instruction is limited.
Principal Responsibilities:
Take on 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 Electronic Code of Federal Regulations (eCFR) 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) for 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 Johnson & Johnson 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 Therapeutic Area (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 (SRP) related queries in Electronic Data Capture (EDC) system. Involvement in other clinical data review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation) is possible.
Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
Qualifications:
A minimum of a Bachelor's degree is required, preferably in Clinical Data Management, Life Sciences or Computer Sciences. Advanced degree (Master’s, PharmD, PhD) preferred.
A minimum of 2 years of experience in the Pharmaceutical industry, Contract Research Organization (CRO), or related industry is required.
Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols is preferred.
Experience in clinical drug development within the Pharmaceutical industry or related industry is required.
Knowledge of current clinical drug development processes is preferred.
Knowledge of applicable international guidelines regarding data management of clinical trials is preferred.
Knowledge of technology platforms and systems to capture and process data (e.g., Medidata Rave, Inform) is preferred.
Understanding of data privacy rules in relation to clinical data exchange is preferred.
Experience in the Oncology Therapeutic Area is preferred.
Team leadership experience is preferred.
Project management experience is preferred.
Experience working with cross-functional stakeholders and teams is required.
Must have excellent verbal and written communication skills.
Must have the ability to adapt to a rapidly changing organization and business environment.
The ability to collaborate with all levels of management across a matrix environment is required.
This position will require up to 10% travel.
The anticipated base pay range for this position in all other U.S. locations 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 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours
This job posting is anticipated to close on July 14, 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.
#LI-Hybrid
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 Analysis
