Clinical Study Manager (Remote) de Virtual, Louisiana em Stryker Corporation

Data de Postagem: 12/5/2019

Resumo do Emprego

Descrição do Emprego

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 (Remote) to join our Joint Replacement Division to be based in Mahwah, NJ or remotely anywhere within the Mid-West, Central or East Coast region of 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.
  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • 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. 
  • Motivated clinical trial launchers. People who bring strategic direction and drive for execution to ensure trials are developed and launched with precision.

What you will do

As the Clinical Study Manager, you will drive the execution of multi-center national and international clinical trials within the Joint Replacement Division at Stryker. You will manage both hip and knee clinical trials, with the opportunity to work on studies at various stages of study start-up, follow-up, and closure. You will strive for excellence in managing, monitoring, and analyzing clinical data, with the primary goal of patient safety and satisfaction.

  • Manage one or more clinical trials, including Investigational Device Exemption, post-approval, post-market surveillance, feasibility, and/or marketing studies.
  • Develop clinical plan strategies and execute on clinical study protocols, timelines, and budget management.
  • Collaborate with Clinical Operations Data Management on data collection, quality control and analysis of clinical trial patient data and radiographic results.
  • Support Regulatory and Marketing functions in strategic clinical data needs.
  • Communicate study results through annual reports, investigator meetings, and global clinical discussions; track study performance through metric-based results.
  • Demonstrate leadership qualities and mentor members of the Clinical Operations team.
  • Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures.

What you need

  • A minimum of a bachelor’s degree with a Science focus required.
  • A minimum of 5 years of experience as a Clinical Research Associate, Clinical Project Manager or experience managing clinical trials required including experience within a Sponsor organization or a Clinical Research Organization.
  • Experience in the medical device field preferred; experience in the pharmaceutical industry considered.
  • Applied knowledge of project management tools.
  • Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management required.
  • Demonstrated interpersonal, written and oral communication as well as organizational planning skills.
  • Strong analytical, technical writing and communication skills.

Work From Home: Remote

Travel Percentage: 30%

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.

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