- Genmab (Plainsboro, NJ)
- …with the teamReview and approve protocol and amendment changesReview the Master Informed Consent Form (ICF)Approve operational plans, manuals, and charters for ... the trialOversee the vendor selection processInitiate and verify the accuracy and completeness of initial Work Orders (WO) and Change Orders (CO)Guide the country selection processCoordinate responses to IEC/IRB commentsMonitor major protocol deviations (PDs)… more
- Novo Nordisk (Plainsboro, NJ)
- …profile + Develop and update the minimum mandatory safety text (MMST) for use in the Informed Consent + Own the safety sections of the labelling for the evolving ... Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs) + Establish and ensure deliverables to/from Data… more
