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Trial Safety Science Manager- NJ

Location: Summit, NJ

Duration: 1 year contract

Title: Trial Safety Science Manager

General Responsibilities

  • Provides support to LPSP in activities relating to monitoring and management of Product's emerging safety profile
  • Supports the logistics of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication
  • May contribute to preparation of materials (Slides, etc.) in preparation of CSC meetings
  • Contributes to signal detection activities by supporting review and synthesis of key safety information; Contributes to signal evaluation and tracking
  • Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile
  • Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.)
  • May provide input and support safety publication strategy

Trial Safety Support

  • Leads execution of all operational safety-related clinical trial activities, and may serve as the Lead Safety Scientist for a compound
  • Supports/May lead the strategy for surveillance activities, as appropriate
  • Participates in ongoing SAE reconciliation between the safety and clinical databases
  • Completes study-level activities generation of Case Management Work aids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF
  • Generates SAE report form, pregnancy report form, completion guidelines for trial-related activities
  • Coordinates the management and preparation for DMC preparation, documentation, and logistical support
  • May review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR

Sthree US is acting as an Employment Business in relation to this vacancy.