Analyst II, Clinical Data Manager

Johnson & Johnson

Analyst II, Clinical Data Manager at Johnson & Johnson developing treatments and pioneering the path from lab to life. Providing oversight and conducting data management activities for clinical trials.

Posted 7/1/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesJuniorMid-Level💰 $92,000 - $148,350 per yearWebsite

About the role

Key responsibilities & impact

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).
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.
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.
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.

Requirements

What you’ll need

A minimum of a Bachelor's degree is required, preferably in Clinical Data Management, Life Sciences or Computer Sciences.
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.

Benefits

Comp & perks

medical, dental, vision, life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension) and savings plan (401(k))
long-term incentive program
vacation - 120 hours per calendar year
sick time - 40 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Data ManagementData ReviewScientific Study ManagementData Quality AssuranceData Integration Requirements

Soft Skills

Team LeadershipCommunicationProblem Solving