Clinical Project Manager -Pathology-Remote
Clinical Project Manager -Pathology-Remote
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Job Description
We are seeking aClinical Project Managerto 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 youll 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 startup conduct and closeout).
- Overseeing projects to ensure completion ontime within scope and budget; tracking project performance to analyze the completion of short and longterm goals.
- Building and maintaining strong collaborative relationships with crossfunctional 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 bachelors 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 years 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.
- Teamoriented with excellent collaboration skills with a crossfunctional team.
- Openminded 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 wellbeing so they can thrive at home and at work at any stage of their wellbeing 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
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. potential base pay range for this role when annualized is $112000.00 $186600.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.
Required Experience:
IC
Employment Type
Full-Time
