Employer Industry: Clinical Research Services

Why consider this job opportunity:
- Salary up to $186,600.00
- Opportunity for career advancement and growth within the organization
- Comprehensive benefits program focused on physical, mental, emotional, financial, and social well-being
- A supportive and inclusive work culture that values employee contributions
- Chance to work on innovative medical treatments that improve patient outcomes

What to Expect (Job Responsibilities):
- Lead the global study team with full accountability for study deliverables regarding quality, budget, and timelines
- Develop key study documents such as protocols, training materials, and study reports
- Oversee planning and operational aspects of companion diagnostics studies sponsored by Pharma partners
- Ensure compliance with regulations, guidelines, and standard operating procedures
- Build and maintain strong relationships with cross-functional leaders and external stakeholders

What is Required (Qualifications):
- Minimum of a bachelor’s degree in Life Science or relevant expertise in the Healthcare Industry
- At least 5 years of prior relevant experience, including over 1 year of project management experience
- Conceptual and practical knowledge of Product Development and Clinical Operations
- Knowledge of or experience with Companion Diagnostic (CDx) studies
- Team-oriented with excellent collaboration skills

How to Stand Out (Preferred Qualifications):
- Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process
- Experience with pathology, tissue diagnostics, or histology for tissue preparation or slide handling
- Familiarity with serology collection, processing, and testing procedures
- Experience or knowledge of Benchmark Ultra tissue staining instruments
- Experience with cobas instruments and Elecsys immunoassays

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