Clinical Project Manager
- Enterprise, Nevada, United States
- Enterprise, Nevada, United States
Über
Location(s) US Remote - NV
About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.
Find your future at Revvity
Overview:
Revvity is seeking a Clinical Project Manager to oversee global In Vitro Diagnostic (IVD) clinical trials from conception through regulatory submission. This role requires strategic project leadership, cross-functional collaboration, and end-to-end accountability for study execution, timelines, budgets, and quality deliverables.
The ideal candidate is an experienced clinical research professional who excels at managing complex, multi-site studies while leading CRAs, coordinating with internal stakeholders, and driving operational excellence. You will serve as the primary point of contact for clinical trial execution, ensuring alignment across Clinical Affairs, Regulatory, Quality, and Commercial teams. This position offers the opportunity to shape diagnostic programs that directly impact global patient care, while mentoring team members and contributing to process improvements across the Clinical Affairs organization.
Why Join Revvity:
At Revvity, you will be part of a lean, high-impact global Clinical Affairs team driving the development of diagnostic solutions that improve patient care worldwide. This position offers the chance to step beyond traditional monitoring and gain broad exposure to regulatory submissions, data management, and study planning. Your contributions will be visible, valued, and essential to advancing our mission.
Key Responsibilities:
Clinical Study Execution
- Contribute to study planning, feasibility, and protocol development
- Identify, evaluate, and activate clinical trial sites
- Support contract and budget coordination during site startup
- Serve as a primary point of contact for site staff throughout the study
Monitoring and Oversight
- Conduct site qualification, initiation, interim monitoring, and close-out visits Ensure compliance with protocol, ICH-GCP, FDA, and applicable local and global regulations
- Verify informed consent and assent processes and patient protections, including pediatric populations
- Apply risk-based monitoring strategies and escalate issues when needed
Data Quality and Reporting
- Perform source document verification, CRF and eCRF review, and query resolution
- Monitor study databases for accuracy, completeness, and data integrity
- Collaborate with data management and biostatistics teams to resolve discrepancies
Cross-Functional Collaboration
- Work closely with Global Clinical Affairs colleagues, regulatory, and operations teams to support study deliverables
- Provide input into study documents and clinical operations planning
Basic Qualifications:
- Bachelor's degree in a scientific or healthcare field or RN/BSN AND a minimum 8 years of clinical research experience including independent monitoring AND
- Experience in Type 1 Diabetes, infectious diseases, or newborn screening clinical studies AND in Vitro Diagnostic (IVD)
Preferred Qualifications:
- Proficiency with CTMS, EDC, and Microsoft Office Suite
- Strong organizational skills with the ability to adapt quickly and manage competing priorities
- Excellent communication and problem-solving skills
- Ability to collaborate effectively in a global, cross-functional environment
- Ability to travel up to 25 percent for site visits and team meetings
- Must possess U.S. work authorization
- Demonstrated ability to manage clinical sites across multiple phases of a study
- Background in pediatric and adolescent research including assent, consent, and age-appropriate protections
- Prior experience supporting FDA or IVDR submissions
- Multilingual capabilities are a plus
- Proficiency with CTMS, EDC, and Microsoft Office Suite
- Strong organizational skills with the ability to adapt quickly and manage competing priorities
- Excellent communication and problem-solving skills
- Ability to collaborate effectively in a global, cross-functional environment
- Ability to travel up to 25 percent for site visits and team meetings
- Must possess U.S. work authorization
- Please Note: This is a customer-funded position. Continued employment is contingent upon the availability of customer funding.
The base salary range for this full-time position is $124, $155, This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into
Sprachkenntnisse
- English
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