Abbott Clinical Project Manager in Princeton, New Jersey
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Point of Care develops, manufactures and markets critical medical diagnostic and data management products for rapid blood analysis. The i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers.
The Point of Care Division in Princeton, NJ has an opening for Clinical Project Manager. This individual will lead/manage the global clinical study strategy. These activities include:
• Establishes, implements, and manages clinical projects including the following activities: project planning and clinical study design development; collaborating with cross functional groups with varied functional expertise; establishing and monitoring clinical timelines and budgets, anticipating schedule impacts and adjusting project team activities as required.
• Develops core clinical documents, including the clinical study protocol, case report forms, informed consent forms, clinical study agreements, investigator manuals, investigator files, and all other necessary documentation for study initiation.
• Identifies, evaluates and audits investigational sites to determine site qualification for participation in clinical trials. Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
• Supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval. Is aware of IRB reporting requirements, ensures maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
• Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures
• Supports research programs process by reviewing clinical research proposals in accordance with Company policies/procedures, and may provide additional clinical expertise and/or administrative support, as necessary.
• Serve as subject matter expert (SME) while leading and/or participating on cross-functional teams.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• Travel requirement: up to 25% US/international
Education and experience qualifications:
• Master's degree or equivalent experience required.
• Typically requires 8+ years of relevant work experience to develop the competence to demonstrate and fulfill the duties and responsibilities of the position.
• Solid hands on clinical study experience.
• Experience leading clinical projects end to end.
• Successful level of leadership experience to lead and influence cross functional collaborations.
• Demonstrated success driving a clinical strategy forward.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com