Note: The job is a remote job and is open to candidates in USA. Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT, connecting talent with opportunities in these domains. The Clinical Project Manager- IVD will be responsible for leading global study teams, ensuring study deliverables meet quality, budget, and timeline expectations while complying with regulatory requirements.
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
Skills
- Experience with Companion Diagnostic (CDx) studies and/or IVD
- Team-oriented with excellent collaboration skills with a cross-functional team
- Open-minded to learn new ways of doing things while leveraging previous experience
- Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process
- 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 and basic knowledge of Clinical Operations or related areas
Benefits
- Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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