Clinical Project Manager- IVD and Cdx jobs in United States
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IQVIA · 1 week ago

Clinical Project Manager- IVD and Cdx

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Project Lead is responsible for ensuring that all studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner while fulfilling sponsor responsibilities and ensuring compliance with regulatory requirements.

AnalyticsHealth CareLife Science
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H1B Sponsor Likelynote

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

Qualification

Companion Diagnostic studiesEU IVDR submission processProject managementLife Science degreeCollaboration skills

Required

Experience with Companion Diagnostic (CDx) studies
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

Incentive plans
Bonuses
Health and welfare and/or other benefits

Company

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)

Funding

Current Stage
Public Company
Total Funding
$3.5B
2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B

Leadership Team

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Chris Colapietro
Vice President, Customer Engagement
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Jonathan Morris
VP & GM US Healthcare
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Company data provided by crunchbase