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Senior Project Manager, Strategic Clinical Research (Remote) in Virtual, Illinois at Stryker Corporation
at Stryker Corporation
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Project Manager, Strategic Clinical Research to join our Joint Replacement Division to be based in Mahwah, NJ or remotely anywhere within the United States.
Who we want
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, advising, and reporting.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
What you will do
As a Senior Project Manager, Strategic Clinical Research, you will oversee the completion of Clinical Evaluation Reports and address Regulatory Body questions requiring clinical data support. You will lead clinical research efforts in the development and execution of strategies to obtain information and support concerning medical devices undergoing clinical investigation, post market surveillance, or marketed/product use evaluation. These clinical programs will facilitate worldwide registration and introduction of new products and provide clinical data and publications of market support and reimbursement of approved devices.
Prepare and analyze clinical data, journal articles and scientific presentations for surgeons and Company personnel and to support regulatory submissions.
Facilitate project plan input, review audit study data or reports, prepare US clearance or approval submissions and draft EU design dossiers.
Support Regulatory Affairs in submission of IDEs, pre-market approval applications, amendments, supplements, and other regulatory submissions with regard to clinical issues.
Oversee and guide Clinical Study Managers in the preparation and development of clinical plans, study protocols and data collection strategies to support regulatory commitments and marketing claims; make recommendations for statistical analyses.
Act as liaison with company business units to identify strategies to bring new products to market which require or would benefit from clinical trial data.
Implement clinical studies with relevant end points and analyze clinical trial data throughout the study; make recommendations.
Participate in preparation of clinical research operating plans and objectives, maintaining alignment with company and departmental strategies.
Mentor Clinical personnel and contribute to their development.
What you need
A Bachelor’s Degree in a Scientific Discipline or health related field required.
A Masters of Science Degree in a Scientific Discipline preferred.
A minimum of 6 years of demonstrated experience in either a Clinical or Regulatory Affairs role or combination of both required.
Experience in the medical device field required.
Demonstrated clinical regulatory experience including knowledge of the regulations, preparation of clinical sections of regulatory documents for FDA and international agencies required.
Experience in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries.
Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations required.
Demonstrated ability to expand application of clinical and regulatory knowledge to interdivisional projects as needed.
Applied knowledge of project management tools.
Work From Home: Remote
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.