Johnson & Johnson

Analyst II, Clinical Data Manager

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • New Jersey • United States

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Salary

💰 $92,000 - $148,350 per year

About the role

  • 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).
  • 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.

Requirements

  • Required 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).
Benefits
  • medical
  • dental
  • vision
  • life insurance
  • short and long-term disability
  • business accident insurance
  • group legal insurance
  • 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
  • volunteer leave – 32 hours per calendar year
  • military spouse time-off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical data managementdata management milestoneseCRFdataset content and structurescientific study data reviewEDC systemcodingSAE reconciliationregulatory compliancequality expectations
Soft Skills
leadershipcommunicationcollaborationorganizationmonitoringproblem-solvingstakeholder engagementprocess improvementattention to detailtime management