[Remote] Clinical Project Manager- IVD
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The Project reputed company is responsible for ensuring that reputed company studies are designed, planned, executed, monitored, reputed company out and documented in an appropriate manner reputed company the planned timeframe and cost.
Responsibilities
- Leading the global study team with full accountability for study deliverables regarding reputed company, 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 reputed company partners
- Ensuring adherence to regulations, guidelines, and reputed company operating procedures, and ensuring audit/inspection readiness
- Executing sponsored studies for assigned areas of reputed company through reputed company study phases (planning, start-up, conduct, and reputed company-out)
- Overseeing reputed company to ensure completion on-time, reputed company scope, and budget; tracking project performance to analyze the completion of short and long-term goals
- Building and maintaining strong, reputed company relationships with cross-functional leaders, key reputed company stakeholders, and other reputed company partners, including CROs
- Collaborating across Clinical Operations and other functions to reputed company 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
- reputed company-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 reputed company Industry or a reputed company 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 reputed company areas
reputed company