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
We are currently seeking a Clinical Study Manager to join our Stryker Spine division to be based remotely anywhere in the United States. This role will support enabling technologies for spinal robotic surgeries.
WHO WE WANT:
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring 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 the Clinical Study Manager, you will be responsible for one or more clinical studies, to include post market surveillance, feasibility, data collection and IDE clinical trials for Mobius Airo CT Spine within the spine division.
Design, develop and write study protocols, Informed Consent templates and Case Report Forms (CRFs)
Perform Investigator qualification process and occasionally perform Investigator qualification visits
Facilitate Institutional Review Board (IRB) submissions and renewals
Train study site personnel in study-related procedures
Strategizing and partnering with the assigned CRO to manage patient recruitment and retention strategies
Prepare monitoring plan, review and follow up on monitoring visit reports, may conduct monitoring visit, when required
Conduct risk analysis and monitor reported adverse events
Serve as primary contact between study site personnel and sponsor regarding study-related issues
Continually monitor study site compliance with protocol and follow-up requirements
Track study metrics on site performance and implement corrective actions
Prepare annual study progress reports and final reports, to include clinical and radiographic data, for FDA, Investigators and IRBs
Support Regulatory Affairs in submission of IDEs, pre-market approval applications amendments, supplements, and other regulatory submissions regarding clinical issues
Participate in product development teams
WHAT YOU NEED:
Bachelor's Degree required; in a health/science-related field preferred.
4+ years of experience as a Clinical Research Associate, Clinical Project Manager/Clinical Study Manager required.
2+ years of experience as a Clinical Project Manager or Clinical Study Manager required.
Previous FDA experience in the medical device industry preferred.
Experience in IDE / Class IIB product clinical trials preferred.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK