Clinical Project Manager- IVD
IQVIA
Clinical Project Manager- IVD
Job Description
Job SummaryThe 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.ResponsibilitiesLeading 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.RequirementsExperience 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 processMinimum 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.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.comIQVIA 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/eoeIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.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.
Locations
- United States of America, North Carolina, Durham
Skills Required
- Companion Diagnosticintermediate
- EU In Vitro Device Regulationintermediate
- or experience with EU In Vitro Device Regulationintermediate
- Healthcare Industryintermediate
- Product Developmentintermediate
Required Qualifications
- Experience with Companion Diagnostic (CDx) studies. (experience)
- Team-oriented with excellent collaboration skills with a cross-functional team. (experience)
- Open-minded to learn new ways of doing things while leveraging previous experience. (experience)
- Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process (experience)
- 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. (experience, 5 years)
- Conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas. (experience)
- Experience with Companion Diagnostic (CDx) studies. (experience)
- Team-oriented with excellent collaboration skills with a cross-functional team. (experience)
- Open-minded to learn new ways of doing things while leveraging previous experience. (experience)
- Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process (experience)
- 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. (experience, 5 years)
- Conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas. (experience)
- 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 (experience)
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. (experience)
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.
- 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.
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