Oversight Monitor – KPS
KPS is looking for Oversight Monitor to join sponsor team. Small FTE approx 0.2 for this year.
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Responsibilities
* Contribute to the development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.
* Define appropriate standards and quality indicators for site management and monitoring.
* Ensure 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.
* Address issues identified with study conduct, monitoring and site management with Sponsor’s management, appropriately communicate/escalate and follow up through resolution.
* Conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities as needed.
* Review the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.
* Assist with translations or verification of translations.
* Implement approved communication plans with external strategic partners or CROs.
* Support collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.
* Review monitoring visit reports for finalization/consistency/issues according to study monitoring plan.
* Utilize available tools/systems to assess vendor and site performance.
* Ensure inspection readiness at the study sites and follow up corrective/preventive actions.
* Maintain good communication and working relationships with investigators, internal stakeholders and external service providers (CROs).
* Provide input into study feasibility for assigned sites/countries/region and support the on-time delivery of a clinical study data, globally (if applicable).
Qualifications
* Computer literacy in appropriate software(s).
* Ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision‑making skills.
* Demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.
* Experience managing all clinical study aspects (developing a protocol to clinical study report).
* Ability to identify, solve and elevate issues that arise at study sites and within site management.
* Comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.
* Project management skills, including simultaneous management of multiple vendors, sites and studies, excellent planning, time management and coordination skills.
* Problem‑solving and sound judgment in regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
* Degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area; other degrees and certifications considered if commensurate with related clinical research experience.
* Minimum 8+ years’ relevant clinical research (or related) experience.
* 6+ years’ experience in monitoring and site management of industry-sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).
* A thorough understanding of the drug development and clinical trial process.
* Ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.
* Ability to participate in preparation, conduct and follow‑up of audits and site inspections.
* Active management experience of countries and sites in a region.
* Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
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