Senior Clinical Study Manager in Virtual, New Jersey at Stryker Corporation

Date Posted: 9/16/2018

Job Snapshot

Job Description

Qualifications / Work Experience Required

  • 3+ years of experience as a Clinical Research Associate, Clinical Project 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

Job Summary

Responsible for the day-to-day management of one or more clinical studies, to include pre-market and/or post-market clinical studies. This individual is responsible for ensuring that assigned studies are being conducted in accordance with GCP/ISO, FDA , and MDR regulations and departmental Standard Operational Procedures.

Essential Duties & Responsibilities may include some or all of the following:

  • Design, develop and write study documents including : protocols, study summaries, PMCF study plans, Informed Consent templates and Case Report Forms (CRFs).
  • Develop and track study budgets.
  • Perform Investigator Qualifications
  • Initiate and manage research agreements with Investigators.
  • Facilitate IRB/EC 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.
  • Perform initiation, monitoring, and close-out visits and provide monitoring visit reports.
  • Oversee Clinical Research Organization (CRO) conduct of monitoring visits, resolve issues and give direction to CRO and sites.
  • Review and monitor study protocol deviations.
  • Report and monitor adverse events/adverse device events.
  • Serve as primary contact between study site personnel and sponsor regarding study-related issues.
  • Collaborate with Medical Affairs, Statistician, Data Management and Clinical IT groups on study design, CRF design, final CRF approval, study set-up of  databases, edit checks, User Aceptance Testing, data entry Quality Control (QC), and data reviews.
  • Review and clarify incoming CRF study data.
  • Continually monitor study site compliance with protocol and follow-up requirements.
  • Track study metrics on site performance and implement corrective actions.
  • Lead data review process.
  • Prepare periodic study status reports for sites and maintain open communication with sites.
  • Assist in preparation of annual study progress reports and final reports
  • Select study files for QC, and follow up on QC findings.
  • Support Regulatory Affairs in submission of IDEs, pre-market approval applications, amendments, supplements, and other regulatory submissions with regard to clinical issues.
  • Oversee study file preparation and archival processes.
  • Represent the Clinical Research group and participate in project team development activities.

Work From Home: Yes

Travel Percentage: Up to 25%

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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