Manager, Clinical Programs - Real World Evidence Generation (Remote) Details

Manager, Clinical Programs - Real World Evidence Generation (Remote)

Stryker - Fremont, CA

Employment Type : Full-Time

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.

We are proud to be named one 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

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker’s Neurovascular Division is seeking to hire a Manager, Clinical Programs to support real-world clinical evidence generation in Fremont, CA or remotely anywhere in the United States.

WHO WE WANT:

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

• Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

• Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

WHAT YOU WILL DO:

Come be part of an amazing team and come make a difference in the world of clinical research about stroke! Someone in the US has a stroke every 40 seconds. This position will make a difference in generating evidence about the positive use of devices in treating this debilitating disease by using real-world evidence, literature studies, secondary analyses, and other strategic approaches to global regulatory submissions. This is a strategic-thinking job that brings tremendous value to the business.

• Be accountable for strategic global submissions for product approvals, product family expansions, indication expansions, regional expansions.

• Manage cost, schedule, performance of the collection of global clinical projects related specifically to strategic use of real-world data and other secondary analysis approaches to advancing clinical stroke evidence across all product lines of the neurovascular division.

• Project manage the ongoing cadence of submissions related to the European Medical Device Regulation (EU MDR).

• Lead all aspects of leading other project manager(s) for attracting, retaining, developing, and aligning talent. Set direction, inspire others, build organizational capability, develop talent, and deliver results.

• Work cooperatively with other aspects of Global Clinical Affairs: other program managers, biostatistics, data management, clinical science, medical writing, medical safety, clinical strategy. Work cooperatively with other departments: Regulatory, Quality, Marketing, PMO.

• Be integrated in all product lines of Stryker’s Neurovascular division and in all aspects of advancing clinical evidence for sharing increased medical knowledge about our stroke devices.

• Partner with and share best practices with other Stryker divisions about real-world data, secondary analyses, and EU MDR strategic approaches.

WHAT YOU NEED:

• Bachelor’s Degree required; Bachelor’s degree in a health/science-related field - preferred.

• A Master’s or Ph.D. degree in health/science-related field or business management - preferred.

• 8+ years’ experience combined experience in clinical Research studies, conducting clinical trials in accordance with FDA and/or global regulatory bodies - required

• 2+ years previous program management, supervisory or people leadership experience - required.

• Working knowledge of GCP, ICH guidelines, and FDA regulations - required

• ACRP CCRA Certification or SOCRA CCRP Category 3 Certification - preferred

• Project Management Professional Certification (PMP) - preferred

This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

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