Analyst II, Global Data Manager
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Mumbai • India
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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).
- Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- 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.
- Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
Requirements
- 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).
- Approx. 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
- Health insurance
- Professional development opportunities
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 deliverablessubmission package reviewinspection readinessregulatory agency auditsstudy Integrated Review Planquality assurancescientific content reviewdata trackingclinical drug development
Soft Skills
leadershipcommunicationorganizationcollaborationstakeholder managementclarityaccuracytiming managementproblem-solvingattention to detail
Certifications
Bachelor's degreeMaster's degreePhD