PKPS is looking for Oversight Monitor to join sponsor team. Small FTE approx 0.2 for this year. /ppThe 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. /ppbr/ppstrongThe (C)OM): /strong /pullicontributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan. /lilicontributes to the definition of appropriate standards and quality indicators for site management and monitoring. /liliensures 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. /liliaddresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution. /liliMay conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed. /lilireviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region. /lilimay assist with translations or verification of translations. /liliimplements approved communication plans with external strategic partners or CROs. /lilisupports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality. /lilireviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan. /liliutilizes available tools/systems to assess vendor and site performance. /liliensures inspection readiness at the study sites and follow up corrective/preventive actions. /lilimaintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs). /liliprovide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable) /li /ulpstrongThe (C)OM) Will Have: /strong /pullicomputer literacy in appropriate software(s). /lilithe ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills. /lilidemonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives. /lilidemonstrated management of all clinical study aspects (developing a protocol to clinical study report). /lilithe ability to identify, solve and escalate issues that arise at study sites and within site management /lilicomprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects. /lilidemonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills. /lilidemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies. /li /ulpstrongThe (C)OM) Will Have: /strong /pullia degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area. /liliother degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist). /lilia 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). /lilia thorough understanding of the drug development and clinical trial process. /lilithe ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary. /lilithe ability to participate in preparation, conduct and follow up of audits and site inspections. /liliactive management experience of countries and sites in a region. /lilithorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. /li /ul