Clinical Project Manager- IVD

We are seeking a Clinical Project Manager to join our global team.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

As the Clinical Project Manager, you will be ensuring that all studies are designed, planned, executed, monitored, closed out, and documented appropriately within the planned timeframe and cost. You will be ensuring sponsor responsibilities are fulfilled while assuring compliance with all applicable regulatory requirements. You will also be responsible for the timeline and budget planning and execution of studies, assigning and ensuring delivery of specific tasks to / from other members of the study team, and providing oversight to outside support including CROs, consultants, and / or medical advisors.

What you’ll be doing :

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.

What We Are Looking For :

Minimum of a bachelor’s degree in Life Science and / or relevant expertise in the Healthcare Industry or a related field, at least 5years 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.

Other equivalent combinations of education, training, and experience may be accepted in lieu of a degree.

The Knowledge, Skills, and Abilities needed for this role :

Knowledge of or 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.

Preferred experience or characteristics across Path and Core Lab :

Knowledge of or experience with Companion Diagnostic (CDx) studies.

Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process to individual ethic committees (EC) and competent authorities (CA) in countries participating in the Pharm or Dia trial.The change from IVD Directive (IVDD) to the Regulation (IVDR) became effective in May 2022 and is a much stricter process. For CDx studies, there is a requirement for a joint Pharma / Dia submission or notification package to be created and submitted to each country participating in the clinical performance study. There are typically feedback rounds with either EC or CA that must be resolved prior to the granting of approval. Each EC and CA must grant the approval or favorable opinion before either Pharma or Dia trial can start in that country.

The GSLs are very involved in the creation of the submission packages and resolution of feedback as well as the close out process once the study has completed for each country.

Preferred experience for Pathology lab :

Experience with pathology, tissue diagnostics, or histology for tissue preparation or slide handling.

Experience or knowledge of the Benchmark Ultra (or competitor tissue staining instrument).

Preferred experience for Core lab :

Experience with serology (serum or plasma) collection, processing, and testing procedures.

Experience or knowledge of the cobas instruments (i.e. cobas e801) and Elecsys immunoassays or competitor serology testing instruments (Beckman, Siemens, Abbott, Ortho).

What We Offer You :

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees’ physical, mental, and emotional, financial, and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https : / / jobs.iqvia.com

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. https : / / jobs.iqvia.com / eoe

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.