Job Description

KPS Life is seeking an experienced freelance part-time Oversight Monitor based in Malaysia.

Primary Purpose and Function:

The primary responsibility of the Oversight Monitor (OM) is to ensure adequate Sponsor oversight of the study conduct and study monitoring within the assigned country or region.

Major Duties and Responsibilities:

The OM:

• contributes to development and execution of the Oversight Monitoring plan.
• will conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans.
• 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.
• addresses issues identified with study conduct, monitoring and site management with Sponsor\'s management, are appropriately communicated/escalated and follows up through resolution.
• reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.
• may assist with translations or verification of translations.
• ensures inspection readiness at the study sites and follow up corrective/preventive actions.
• maintains good communication and working relationships with investigators/site staff and assigned monitors.

Competencies:

The OM will have:

• computer literacy in appropriate software(s).
• excellent interpersonal (written and verbal) and decision-making skills.
• demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.
• demonstrated management of monitoring and site management tasks.
• the ability to identify, solve and escalate issues that arise at study sites and within site management
• comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.
• excellent planning, time management and coordination skills.
• demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.

The OM will have:

• a degree (BSc 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 (e.g., diploma or associate degree RN, certified medical technologist).
• a minimum of 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.
• the ability to participate in preparation, conduct and follow up of audits and site inspections.
• thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.

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KPS Life