Clinical Project Manager- IVD and Cdx at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Medical DevicesIndustries

Requirements

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

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 implement best practices across Clinical Operations

Skills

Companion Diagnostics

CDx Studies

Project Management

Clinical Operations

EU IVDR

Study Protocols

CRO Oversight

Regulatory Compliance

Timeline Management

Budget Management

Stakeholder Collaboration

Audit Readiness

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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