at Stryker in Cary, Illinois, United States
Job Description
Why join Stryker?
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com
We are currently seeking a Clinical Study Manager , to join our Medical Division. This is an individual contributor Hybrid position, located in either Portage, Michigan or Cary, Illinois.
Who We Want
+ Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
+ Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
+ Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
+ 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.
What you will do
As a Clinical Study Manager , you will assume overall responsibility for executing on the clinical evidence strategy for medical devices, pharmaceuticals, and cosmetics for our Sage business unit. You will have the autonomy to create and implement clinical study strategies in support of new and continued global market access. Come make an impact for caregivers and patients alike!
+ Execute on the clinical evidence strategy for medical devices, pharmaceutical products, and biocides and support development of this strategy. Create and execute clinical regulatory strategies in support of new and continued global market access.
+ Partner with stakeholders (e.g., Marketing, Research & Development/New Product Development) to develop clinical evidence strategies for the short- and long-term. Provide clinical and scientific expertise to influence business strategy and drive informed planning and decision making.
+ Responsible for all aspects of clinical research including preparation, study design, execution, and reporting, ensuring alignment to Good Clinical Practice (GCP). Generate clinical data for the business in alignment with the strategy, including pre- and post-market clinical trials, efficacy studies, registries, surveys, and literature searches.
+ Manage the process for clinical regulatory documentation preparation and submissions for clinical studies (e.g., IDE submissions, IRB/EC submissions).
+ Member of Research & Development/New Product Development teams. Support claims development, especially those requiring clinical data to substantiate.
+ Define a study publication strategy in partnership with stakeholders, including preparation of manuscripts, conference presentations/posters, white papers, and customer-facing promotional materials. Assist customers with manuscript/presentation preparation.
+ Provide budget input aligned to planned clinical strategy for clinical studies and clinical evaluations.
+ Act as Stryker liaison and build partnerships with clinical research organizations (CROs), data management vendors, medical writers, and other external parties to ensure robust and scalable clinical study and clinical evaluation support.
+ Review and approve collateral material for the Clinical Affairs function.
+ Maintain current knowledge in areas of expertise through professional development (e.g., attending conferences and professional association meetings). Share knowledge with Clinical Affairs team and cross-functional partners, as appropriate.
+ B.S. in biomedical engineering, science, nursing or related field. Advanced degree strongly preferred.
What you need
+ B.S. in biomedical engineering, science, nursing, or related field. Advanced degree strongly preferred.
+ At least 4 years of relevant clinical research experience, preferred in clinical study management.
+ Strong knowledge of FDA regulations, International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines, and ISO14155 required.
+ Preferred experience in device and pharmaceutical industries, including product development.
+ Preferred clinical research or project management certification (e.g., CCRP, ACRP, PMP)
+ Ability to exercise sound judgment in independent decision making required.
+ Ability to take initiative and manage multiple projects in a dynamic environment required.
+ Ability to influence without authority and work collaboratively with internal and external partners required.
+ Strong planning, organizational, communication, negotiation, problem-solving, and presentation skills required.
+ Excellent technical writing and analytical skills required.
+ Experience at a medical device manufacturer preferred.
+ Experience with global clinical studies preferred.
+ Experience in biostatistics preferred (SQL, MATLAB, or R).
About Stryker
Our benefits:
+ 12 paid holidays annually
+ Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
+ Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page (https://careers.stryker.com/referrals/)
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
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.
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