Associate Manager, Clinical Affairs in Allendale, NJ at Stryker Corporation

Date Posted: 11/21/2020

Job Snapshot

Job Description

Who you are

  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

  • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

  • 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.

What you will do

As an Associate Manager, Clinical Affairs, you lead diverse teams of clinical staff in clinical study management activities, supervise and develop clinical staff and provide leadership and guidance to less experiences team members through reviewing their work and assisting in their training.

Responsibilities include

  • Manage the day-to-day activities of one or more global studies including developing, tracking and managing budgets

  • Responsible for the assurance of protocol compliance and data integrity by assuring adherence to GCPs, FDA regulations, EU MDR regulations, and department Standard Operational Procedures

  • Ability to lead a team to deliver results on multiple, simultaneous, complex projects

  • Supervise staff members, including performance management and professional development

  • Lead and guide team in the design, development and writing clinical study protocols in conjunction with physician advisors

  • Lead and guide the team in the preparation of annual study progress reports and final reports, to include clinical and radiographic data, for FDA, Investigators and IRBs

  • Review and monitor study protocol deviations

  • Conduct risk analysis and monitor reported adverse events

  • Prepare and maintain patient recruitment and retention strategies

  • Track study metrics on site performance, devise and implement corrective actions

  • Assist Investigators with manuscript preparation for submission to peer reviewed journals or podium presentations

  • Perform all study-related activities as necessary including study and site management, communication and monitoring

  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets

  • May lead the development of new systems and procedures

  • Plans, conducts, and supervises assignments

  • Reviews progress and evaluate results

What you need

  • Bachelor’s degree required; Focus in science or health-related field such as Biology, Nursing or Biomedical Sciences preferred

  • Minimum 7 years of professional clinical experience with at least 5 years experience conducting Investigational Device Exemption (IDE) and post-marketing clinical trials of medical devices

  • Minimum 1 or more years of experience managing direct reports

Preferred Qualifications

  • Advanced degree

  • ACRP or SoCRA certification

  • Medical device industry experience in imaging, navigation and robotics

Work From Home: Occasional

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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