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
- Gather and/or review content and integration requirements for eCRF and other data collection tools
- Establish conventions and quality expectations for clinical data
- Review clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency
- Ensure compliance with regulatory guidelines
- Plan and track content, format, quality, and timing of applicable data management deliverables
- Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved
- Identify and participate in process, system, and tool improvement initiatives
Requirements
- Required Minimum of a Bachelor's degree (e.g., BS, BA) or equivalent professional experience
- 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
- Strong written and verbal communications skills (in English)
- Team leadership experience (preferred)
- Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols (preferred)
- In-depth knowledge of current clinical drug development processes (preferred)
- In-depth knowledge of applicable international guidelines regarding data management of clinical trials (preferred)
- 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
Benefits
- medical, dental, vision, life insurance
- short and long-term disability
- business accident insurance
- group legal insurance
- 401(k)
- annual performance bonus
- vacation – 120 hours per calendar year
- sick time – 40 hours per calendar year
- holiday pay, including Floating Holidays – 13 days 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
- 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 collection toolsclinical drug developmentscientific content reviewregulatory compliancedata management deliverablesprocess improvementsystem improvementtool improvement
Soft Skills
leadershipcommunicationteam collaborationorganizational skillsattention to detail