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Clinical Trial Safety Manager

Edison-New Brunswick Metro Area, NJ

Post Date: 10/13/2017 Job ID: JN -102017-20238 Job Type: Clinical
  • -- Pharmacy/Nursing (eg, BSN, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience
    -- At least 3 years relevant pharmaceutical/CRO industry experience
    -- Experience in clinical R&D, clinical safety, and/or safety case management
    -- Knowledge of the global safety environment, international regulations and guidance documents
    -- Appreciation of the product development life cycle and clinical trials
    -- Working knowledge of safety data capture in clinical trial settings and familiarity with clinical database systems
  • Provide safety support and surveillance for clinical studies
    -- Assist study teams in implementing, executing and concluding trials
    -- Participate in SAE reconciliation
    -- Review study-specific protocol, ICF, CRF
    -- Review study-specific CRO-related documents (SOW, monitoring plans, TORO, contracts, etc)
    -- Generate study-specific SAE reporting plan, SAE report form/pregnancy report form/completion guidelines, risk/benefit assessment for EU CTAs
    -- Provide safety training to site and study personnel
    -- Train case processing staff in new protocols
    -- Complete additional study start up activities
    -- Review clinical cases for internal discrepancies and liaise with case management on corrections
    -- SMT / DMC preparation, documentation, and logistical support
    -- Contribute to & participate in product review meetings
    -- Review study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs])
    -- Provide safety strategy and guidance to medical writers for Clinical Study Report (CSR) & perform review of CSR
    -- Respond to Ad Hoc Investigator / IRB / EC Queries
    -- Familiarity with computer applications such as ARISg, Business Objects/Business Intelligence, -- Familiarity with MedDRA coding and SMQ use

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