Clinical Project Manager- IVD

NCBiotech; Durham (NC); On-site; USD 93,100 - 232,800; Full time

Job summary

IQVIA in Durham, NC seeks a Project Lead to ensure studies are designed, planned, executed, monitored and closed within time and cost constraints. You will guarantee sponsor responsibilities and regulatory compliance, while overseeing budget planning and CROs or external advisors.

The role involves leading global study teams, delivering key documents, and ensuring audit readiness across all study phases. Strong collaboration across Clinical Operations is essential.

Qualifications

• Experience with Companion Diagnostic (CDx) studies.
• Team-oriented with cross-functional collaboration.
• Open to learning new methods while leveraging past experience.
• Knowledge of EU IVDR submission process.
• Bachelor’s degree in Life Science and 5+ years in Healthcare or related field, with at least 1 year of project management.
• Understanding of Product Development and Clinical Operations basics.

Responsibilities

• Lead global study team with accountability for quality, budget, and timelines.
• Develop 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 and audit readiness.
• Executing sponsored studies through all study phases (planning, start-up, conduct, close-out).
• Overseeing projects to ensure completion on-time, within scope, and budget; tracking performance.
• Building and maintaining relationships with cross-functional leaders, internal/external stakeholders, and CROs.
• Collaborating across Clinical Operations to implement best practices.

Skills

Leadership

Collaboration

Open-minded

Regulatory knowledge

Education

Bachelor’s degree in Life Science

Job description

Job Summary

The Project Lead is responsible for ensuring that all studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner within the planned timeframe and cost; ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements. Responsible for the timeline and budget planning and execution of studies. Assigns and ensures delivery of specific tasks to/from other members of the study team. Provides oversight to outside support including CROs, consultants and/or medical advisors.

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.

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.

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

EEO Minorities/Females/Protected Veterans/Disabled