Brief Description:
Provides clinical project oversight and support to the project management (PM) team. Provides oversight and manages clinical monitoring and site management portions of projects in accordance with ICH/GCP, CFR guidelines, regional or country regulations/ legislations, as well as UBC and sponsor SOPs.
Specific job duties:
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Thorough knowledge of sponsor specific project requirements, scope, protocol and timelines
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Provides oversight of the day-to-day clinical operations of US, European and/or multi-national global projects from start-up through close-out
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Reviews and approves monitoring reports and letters within UBC and/or sponsor timelines
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Leads and assists with UBC and project specific training
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Ensures appropriate visit scheduling per protocol; tracks, reports and escalates adherence to site visit schedule, trip report metrics and documentation of completed tasks
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Provides oversight of the issues & actions and protocol deviations to ensure timely resolution per UBC and/or sponsor timelines
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Serves as primary liaison for monitoring issues, escalating to PM and/or Evidence Development Operations (EDO) Manager when appropriate
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Assists with preparation and leading of sponsor, project team and UBC meetings
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Assists as back-up for PM and may be primary contact for UBC/sponsor interaction
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Collaborates with PM to provide input into resourcing, analyzing cost variances, out-of-scope management, and conducting revenue recognition as applicable
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Coordinates site assignments for team in conjunction with PM and EDO Manager
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Monitors clinical operations aspects of the project against the established plans, SOPs and KPIs ensuring compliance
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Assists PM with the creation and maintenance of project specific documents
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Responsible for maintenance of audit-ready project systems (eTMF, CTMS, project specific systems) as related to clinical operations
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Mentors and supports project team
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May include reviewing the preparation, submission and tracking of Competent Authority (CA), Central and Local Ethics Committee and other regulatory applications, as per country requirements
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May include oversight of contract negotiation activities with the sites as per country requirements
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May be required to perform site monitoring as needed.
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May review and provide oversight of study feasibility assessments
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May assist PM and EDO Manager with management of Vendor CRAs
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May require up to 30% travel
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Assists with other duties as assigned
Supervisory Responsibility:
Desired Skills and Qualifications:
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Bachelor’s degree in Health Care/Life Science preferred or equivalent industry experience
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Minimum of 5+ years of site management experience required with preference of 2 years field monitoring experience
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Knowledge and understanding of the local country laws applicable to clinical trials and observational studies
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Proficient in the operational methodologies of clinical trials and observational studies
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Thorough knowledge of medical terminology, ICH/GCP and UBC SOPs
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Excellent written and verbal communication skills in English and local language
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High attention to detail
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Excellent critical thinking and resolution skills
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Displays leadership, organizational, communication, time management and interpersonal skills
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Proven skills with CTMS, eTMF, EDC, Microsoft Office, basic computer software and sponsor specific systems
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Ability to work independently and within a cross-team environment.
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Confident in taking responsibility for operational day-to-day project oversight
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Ability to coordinate monitoring project activities at local, national, and international studies
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
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