Position: Clinical Project Manager – IVD
📍 Location: Durham, North Carolina (Remote/Home-based)
🕒 Employment Type: Full-Time
💼 Job ID: R1504586
🌐 Additional Locations: California | North Carolina | Remote
About IQVIA
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence, accelerating the development and commercialization of innovative medical treatments.
🔗 Learn more: https://jobs.iqvia.com
Position Overview
The Clinical Project Manager ensures that all clinical studies are designed, planned, executed, monitored, closed out, and documented appropriately within budget and timeline. This role guarantees sponsor responsibilities are fulfilled while maintaining compliance with all applicable regulatory requirements.
The manager will oversee study timelines, budgets, task delegation, and external support (CROs, consultants, medical advisors) to ensure successful study execution.
Key Responsibilities
1. Study Leadership & Oversight
Lead global study teams with full accountability for quality, budget, and timelines.
Develop and maintain key study documents (Design Validation Plan, protocol, study training materials, study forms, templates, study report).
Oversee planning and operational aspects of companion diagnostics (CDx) studies sponsored by Pharma partners.
Ensure compliance with regulations, guidelines, and SOPs; maintain audit/inspection readiness.
Execute studies across all phases (planning, start-up, conduct, close-out).
2. Project Management
Oversee projects to ensure completion on time, within scope, and budget.
Track project performance for short- and long-term goal completion.
Assign tasks and ensure delivery from study team members.
Provide oversight to external partners including CROs, consultants, and medical advisors.
3. Collaboration & Communication
Build and maintain strong cross-functional relationships with internal/external stakeholders and alliance partners.
Collaborate with Clinical Operations and other functions to develop and implement best practices.
Qualifications
Education:
Bachelor’s degree in Life Sciences or related healthcare field, or equivalent experience.
Experience:
Minimum 5 years of relevant experience, including >1 year of project management experience.
Knowledge or experience with Companion Diagnostic (CDx) studies.
Knowledge or experience with EU In Vitro Device Regulation (IVDR) submission process.
Skills & Competencies:
Team-oriented with excellent collaboration skills.
Open-minded to learn new methods while leveraging prior experience.
Conceptual and practical knowledge of Product Development and basic Clinical Operations.
Preferred Experience (Pathology / Core Lab):
Pathology Lab: Tissue diagnostics, histology, Benchmark Ultra or competitor tissue staining instruments.
Core Lab: Serology collection, processing, testing, Cobas instruments (cobas e801), Elecsys immunoassays, or competitor instruments.
Experience with IVDR submission packages, ethics committee (EC) and competent authority (CA) approvals, and feedback resolution.
Compensation & Benefits
Base Pay Range (annualized): $93,100 – $232,800
Actual base pay may vary based on qualifications, experience, location, and schedule
Eligible for incentive plans, bonuses, and additional benefits depending on the position
Equal Opportunity Employer
IQVIA provides employment consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.
🔗 Equal Opportunity Statement
📩 Apply Now: IQVIA Careers – Clinical Project Manager IVD
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