• Job Description

  Req#: R496158
  Work Flexibility: Remote

  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 Manager, to join our Trauma & Extremities Division. This is an Individual Contributor fully remote position, located in the United States. Preference will be given to candidates located in the Midwest or Eastern US. This job may not be filled or performed in Colorado.

  Who We Want

  Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  Self-directed initiators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

  Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations

  Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

  What you will do

  As a Clinical Study Manager, you will interact directly with institutions and investigators, execute clinical research initiatives, and ensure alignment with strategic goals. Must have knowledge in reference to good clinical practices regulations and standard operating procedures.

  • Work in a virtual team environment, requiring that you be highly engaged, communicate effectively, and participate in project team meetings.
  • Take lead roles in the development and execution of studies designed to support clinical evidence of device safety and performance.
  • Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment.
  • Build and maintain excellent working relationships with clinical site staff, key opinion leaders and colleagues.
  • Develop, maintain, and adhere to study project plans and timelines.
  • Coordinate and execute research projects, including study training, site identification and initiation, ethics approval, contracting, invoicing, auditing and monitoring, and close-out activities.
  • Liaise with vendors and directly managing CROs and other outsourced activities.
  • Develop and track study budgets.
  • Monitor study conduct and progress, proactively identify and resolve issues which may impact delivery of the study to the necessary regulations and standards, timelines, or budget.
  • Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, GCPs, and Stryker Standard Operating Procedures.
  • Maintain a high level of professional expertise through familiarity with scientific literature, product portfolio, and the competitive and healthcare environments.
  • Execute clinical trial research, evaluate and analyze clinical data, prepare and review clinical study reports.
  • Maintain clinical and regulatory files, accurate and timely tracking and documentation.
  • Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
  • Support new and ongoing clinical research activities, ensure efficient and timely processing of confidentiality and clinical agreements.
  • Support the development of study materials including informed consent documents, data collection tools, patient instruction guides, protocols, reports and summaries.
  • Conduct clinical monitoring and/or auditing of field sites to supervise and coordinate clinical studies.

  What you need

  • A minimum of a bachelor’s degree (B.S. or B.A.) required, preferably with Health Sciences or other related technical discipline required.
  • 4+ years’ experience as a Clinical Research Associate, Clinical Project Manager, Study Manager or other related professional role.
  • Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management.
  • Demonstrated interpersonal, written and oral communication skills as well as excellent organizational and time management skills in a fast-paced environment.
  • Applied knowledge of project management tools
  • Fluency in English is essential
  • Strong proficiency in basic computer skills, document management, and Microsoft Office Suite applications

  • $83,000 - $176,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives. Benefits (including but not limited to health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

  Travel Percentage: 20%

  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.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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