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Clinical Project Manager-Pathology
| Company | IQVIA |
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| Location | Durham, NC, USA |
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| Salary | $112000 – $186600 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Minimum of a bachelor’s degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field
- At least 5 years of prior relevant experience including > 1 year’s project management experience
- Conceptual and practical knowledge of Product Development
- Basic knowledge of Clinical Operations or related areas
- Knowledge of or experience with Companion Diagnostic (CDx) studies
- Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process
Responsibilities
- Leading the global study team with full accountability for study deliverables regarding quality, budget, and timelines
- Developing key study documents (e.g., Design Validation Plan, protocol, study training materials, study forms and templates, study report)
- Overseeing planning and operational aspects of companion diagnostics studies sponsored by Pharma partners
- Ensuring adherence to regulations, guidelines, and standard operating procedures, and ensuring audit/inspection readiness
- Executing sponsored studies for assigned areas of focus through all study phases (planning, start-up, conduct, and close-out)
- Overseeing projects to ensure completion on-time, within scope, and budget; tracking project performance to analyze the completion of short and long-term goals
- Building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners, including CROs
- Collaborating across Clinical Operations and other functions to develop and implementing best practices across Clinical Operations
Preferred Qualifications
- Knowledge of or experience with Companion Diagnostic (CDx) studies
- Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process to individual ethic committees (EC) and competent authorities (CA)
- Experience with pathology, tissue diagnostics, or histology for tissue preparation or slide handling
- Experience or knowledge of the Benchmark Ultra (or competitor tissue staining instrument)
- Experience with serology (serum or plasma) collection, processing, and testing procedures
- Experience or knowledge of the cobas instruments (i.e. cobas e801) and Elecsys immunoassays or competitor serology testing instruments (Beckman, Siemens, Abbott, Ortho)
