Qureos Mentor

KPS Life

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

Clinical Oversight Manager (COM)

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Clinical Oversight Manager (COM)