Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Stryker

Clinical Study Manager (Remote) (R450626)

Branch Manager

Manager

Yearly

No

Leesburg, Virginia, United States

About Stryker

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


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 Clinical Study Manger to be based in or Leesburg, VA 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.

  • Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.

Position summary

Manage one or more clinical studies, to include Investigational Device Exemption (IDE), post approval, post-market surveillance, feasibility and/or marketing studies. Ensure that assigned studies are being conducted in accordance with Good Clinical Practices, Food and Drug Administration (FDA) and/or other applicable national regulations and department Standard Operational Procedures.

What you will do.

  • Design, develop and write study protocols, Informed Consent templates and Case Report Forms (CRFs)
  • Develop and track study budgets
  • Perform Investigator qualification process and occasionally perform Investigator qualification visits
  • Initiate investigator agreements with Investigators
  • Facilitate Institutional Review Board (IRB) submissions and renewals
  • Lead and monitor device accountability process
  • Train study site personnel in study-related procedures
  • Prepare and maintain patient recruitment and retention strategies
  • Prepare monitoring plan, review and follow up on monitoring visit reports, may conduct monitoring visit, when required
  • Review and monitor study protocol deviations
  • Conduct risk analysis and monitor reported adverse events
  • Serve as primary contact between study site personnel and sponsor regarding study-related issues
  • Collaborate with Data Management and Clinical IT groups on CRF design, final CRF approval, study set-up of databases, edit checks, User Acceptance Test, data entry Quality Control (QC), data review, and SAS reports
  • Review and clarify incoming CRF study data
  • Reviews radiographic data and participates in X-ray reviews
  • Continually monitor study site compliance with protocol and follow-up requirements
  • Develop solutions based on best practices and customer feedback.
  • Solicit input from managers and exercise independent judgment in providing recommendations to the business.
  • Effectively facilitate discussions with and deliver communications to large groups of people.
  • Communicate telephonically and via email and other electronic means.
  • Ability to effectively navigate Workday and Microsoft Office Suite.
  • Ability to handle multiple concurrent tasks and changing priorities

Education & special trainings

  • Bachelor's degree in sciences or health related field
  • ACRP, SoCRA, and/or PMP certification preferred

What You Need

  • 5+ years of experience as a Clinical Research Associate, Clinical Project Manager/Clinical Study Manager or equivalent external position
  • Experience in the medical device field preferred; experience in the pharmaceutical industry considered
  • Applied knowledge of project management tools
  • Demonstrated interpersonal, written and oral communication skills
  • Demonstrated organization and planning skills
  • Demonstrated success in a team-based environment preferred
  • Demonstrated knowledge and application of personal computer systems and desktop applications
  • Able to work with minimal supervision, set priorities and be flexible within a fast-paced environment.

Physical & mental requirements

Must be able to:

  • Exercise independent judgment with strong attention to detail
  • Analyze, understand and communicate complicated issues to Managers and Employees to ensure understanding
  • Develop solutions based on best practices and customer feedback.
  • Solicit input from managers and exercise independent judgment in providing recommendations to the business
  • Effectively facilitate discussions with and deliver communications to large groups of people
  • Communicate telephonically and via email and other electronic means.
  • Ability to effectively navigate Workday and Microsoft Office Suite.
  • Ability to handle multiple concurrent tasks and changing priorities

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.