At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The point-of-care (POC) testing industry is changing faster than ever. At Abbott Point of Care, we've stayed ahead of the curve. We are a worldwide leader in fundamentally changing healthcare delivery at the point of care with solutions that are intuitive, innovative, reliable, and cost-effective for our customers.
The Point of Care Division in Princeton, NJ has an opening for Clinical Project Manager. This individual will lead/manage global clinical studies. 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.
• Manage clinical publications strategy; Serve as subject matter expert (SME); lead and/or participate on cross-functional teams
• Actively participate in the planning and supporting of clinical relationships with Key Opinion Leaders (KOLs) and speakers;
All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: 30-40%
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.
• Experience with regulations and standards affecting the medical diagnostic industry.
• Experience with or exposure to Good Clinical Practices.
• Ability to clearly, concisely and accurately convey communications.
• Ability to form and develop interpersonal, professional relationships and exhibit socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Demonstrated initiative and problem-solving skills.
• Familiarity with desktop computer office software.
Clinical Affairs / Statistics
APOC Point of Care
United States > Princeton : 400 College Road East
Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
We are a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Our products span the continuum of care, from nutritional products and laboratory diagnostics through medical devices and pharmaceutical therapies. Our comprehensive line of products encircles life itself - addressing important health needs from infancy to the gold...en years.
Abbott has sales, manufacturing, research and development, and distribution facilities around the world, close to where our customers need us to be. We are recognized for our global reach and our ability to serve our customers around the world.