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Project Manager, Applied Research

Abbott Laboratories - Plano, TX

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Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the 1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson''s disease and essential tremor symptoms, steering away from side effects.Our location in Plano, TX currently has an opportunity for a Project Manager, Applied Research. The Project Manager will coordinate day-to-day program activities of small to large clinical studies, contribute to clinical study strategy design and drive execution. They will analyze and influence resources across the organization to ensure programs meet their agreed upon milestones and deliverables. They will represent our organization to research sites, report progress on various project activities, and collaborate with team members on research program recommendations, risks, and resolution of issues to senior leadership team.WHAT YOU''LL DO Lead project deliverables towards program objectives. Lead activities across numerous functions to meet the objectives of a given program including scope, budget, and schedule.Ensure both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.Configure and ship devices for clinical studies.Draft study related materials such as: patient brochures, patient recruitment material, and presentations. Draft protocol summary, annual report, and other study reports.Draft informed consent documents and ensures all required elements are included. Develop for review draft Case Report Forms and associated edit logic.Assist with site nomination, qualification, and selection processes. Provide product/protocol specific support and training to internal and external clinical consultation with study management, the assigned field clinical personnel and appropriate inhouse personnel, coordinate the start-up and maintenance of the clinical study sites.Review and analyze data and documents for accuracy and completeness. Can lead study team to clean and review data. Create and process data queries.Assist with preparation, follow-up, and resolution of findings from monitoring visits and audits. Independently reviews site compliance and raises issues to study management.Serve as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate. Communicate and collaborate with all levels of employees, customers, contractors, and vendors.Apply general clinical research processes and regulatory knowledge to actively improve processes and efficiencies. Understand business environment and relate extensive knowledge of internal and external technological activities to terface with senior management on significant matters, often requiring the coordination of activity across organizational units.Participate in the development of other technical contributors by facilitating training and providing feedback and guidance.May lead a project team. Collaborate closely with functional core team leaders.Provide scientific expertise throughout development, execution and reporting of clinical studies.Participate in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback and ply with worldwide medical device regulations including U.S. FDA, company policies and Good Manufacturing Practices.EDUCATION AND EXPERIENCE YOU''LL BRINGRequiredBachelor''s degree in science, engineering, medicine or similar discipline. Minimum 5 years experience leading projects in a medical device, biomedical or high technology industry.Ability to work in a matrixed and geographically diverse business environment.Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-task, prioritize and meet deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. Preferred Expertise in one or more of the following strongly preferred: deep brain stimulation, movement disorders, neuroscience, neuroimaging, brain-machine interface.Advanced degree (Masters of Science or PhD) preferred with an academic focus in natural science, nursing, bioengineering or a related academic field. Excellent understanding of all aspects of clinical research. General familiarity with neuromodulation and digital health technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment. Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP). Work habits include organization, coordination of many tasks, accuracy, and attention to detail.Experience working in a broader enterprise/cross division business unit model.WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer:• Training and career development, with onboarding programs for new employees and tuition assistance• Financial security through competitive compensation, incentives and retirement plans• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs• Paid time off• 401(k) retirement savings with a generous company match• The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Created: 2021-11-29

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