Senior Data Manager
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • United States
Visit company websiteExplore more
Salary
💰 $105,000 - $169,050 per year
Job Level
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
- Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements
- Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary
- Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables
- Ensure deliverables are on time
- Take a leadership role to obtain and share best practices with internal partners
- Identify and communicate lessons learned, best practices and frequently asked questions at the trial level
- Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency
- Identify and participate in process, system, and tool improvement initiatives
- Lead others in implementing process, system, and tool improvement initiatives
Requirements
- Bachelor's degree (e.g., BS, BA) or equivalent professional experience required, preferably in Clinical Data Management, Health, or Computer Sciences
- Advanced degrees preferred (e.g., Master, PhD)
- Approximately 4 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry
- Experience in clinical drug development within the pharmaceutical or related industry
- Experience working with cross-functional stakeholders and teams
- Strong written and verbal communications skills (in English)
- Team leadership experience
- Strong 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
- Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.)
- In-depth knowledge of project management and techniques and knowledge of team management principles
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- retirement plan (pension)
- savings plan (401(k))
- annual performance bonus
- vacation up to 120 hours per year
- sick time up to 40 hours per year
- holiday pay up to 13 days per year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdata management processesproject managementdata collection toolseCRFscientific conceptsdata privacy rulesCDISCSDTMCDASH
Soft skills
leadershipcommunicationteam leadershipcross-functional collaborationorganizational skillsproblem-solvingbest practices sharinglesson identificationprocess improvementstakeholder engagement
Certifications
Bachelor's degreeMaster's degreePhD