P KPS is looking for Oversight Monitor to join sponsor team. Small FTE approx 0.2 for this year. /pp The primary responsibility of the (Clinical) Oversight Monitor (C)OM) is to ensure adequate Sponsor oversight of the conduct, monitoring and management of one or more clinical studies and assigned monitors at clinical study sites, within the assigned country or region. /p pb The (C)OM): /b /pulli contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan. /lili contributes to the definition of appropriate standards and quality indicators for site management and monitoring. /lili ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards. /lili addresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution. /lili May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed. /lili reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region. /lili may assist with translations or verification of translations. /lili implements approved communication plans with external strategic partners or CROs. /lili supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality. /lili reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan. /lili utilizes available tools/systems to assess vendor and site performance. /lili ensures inspection readiness at the study sites and follow up corrective/preventive actions. /lili maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs). /lili provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable) /li /ulpb The (C)OM) Will Have: /b /pulli computer literacy in appropriate software(s). /lili the ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills. /lili demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives. /lili demonstrated management of all clinical study aspects (developing a protocol to clinical study report). /lili the ability to identify, solve and escalate issues that arise at study sites and within site management /lili comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects. /lili demonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills. /lili demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies. /li /ulpb The (C)OM) Will Have: /b /pulli a degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area. /lili other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist). /lili a minimum of 8+ years’ relevant clinical research (or related) experience. /lili6+ years’ experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent). /lili a thorough understanding of the drug development and clinical trial process. /lili the ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary. /lili the ability to participate in preparation, conduct and follow up of audits and site inspections. /lili active management experience of countries and sites in a region. /lili thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. /li /ul