Opportunity DetailsOn Assignment
Clinical Oversight Manager (COM) - USARemote East Coast USA
The primary responsibility of the (Clinical) Oversight Manager (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.
The (C)OM):
- contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.
- contributes to the definition of appropriate standards and quality indicators for site management and monitoring.
- 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.
- May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed.
- 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.
- implements approved communication plans with external strategic partners or CROs.
- supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.
- reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan.
- utilizes available tools/systems to assess vendor and site performance.
- ensures inspection readiness at the study sites and follow up corrective/preventive actions.
- maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs).
- provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable
The (C)OM) will have:
- computer literacy in appropriate software(s).
- the 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.
- demonstrated management of all clinical study aspects (developing a protocol to clinical study report).
- 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.
- demonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses 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 (C)OM) will have:
- a 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 (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 assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.
- the 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.
