Operational Studies Project Manager, Health Technologies

Santa Clara Valley (Cupertino), California, United States
Hardware

Summary

Posted:
Weekly Hours: 40
Role Number:200203625
The Health Technologies Group conceives of and proves out exciting new technologies for Apple’s products and features. We are seeking an Operational Studies Project Manager to lead human study efforts in collecting data to support development and validation of health sensors and algorithms. This role interacts with all engineering design fields, data analysis, legal, business development, and other project management teams. Our team works in highly innovative yet dynamic environment with high sense of urgency. If this sounds like you, read on!

Key Qualifications

  • We are looking for an operation project manager with at least 5 years of project management experience
  • Strong human research background with clear understanding of user study lifecycle
  • Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations, standards, and guidance.
  • You are proficient in conducting virtual and/or remote clinical studies with Hardware / Software devices
  • Experience working with and managing external sites and/or managing vendors
  • Strong organizational and leadership skills with a track record of timely project delivery
  • Ability to influence cross-functional teams and collaborate effectively to embrace best practices
  • Self-motivated and proactive with critical thinking and resourcefulness to drive the project to success
  • Strong presentation skills with crisp communication in both verbal and written areas.
  • Some travel is required, approximately 15-20%
  • Experience in performing audits with various regulatory agencies a nice to have.

Description

- Operation Studies Project Managers are responsible for managing the study execution, communicating on study milestones and schedule internally and with external sites and/or vendors. - The OPM should have knowledge of Global GCP requirements and how they apply to the execution of studies. - In this role, you must be able to prioritize issues and track the details as well as be in touch with the big picture. - You are a fearless organizer who are ready to work with the highly skilled internal hardware and software design teams as well as external sites and vendors to achieve a successful study. - You have a strong understanding of human studies research lifecycle, data collection requirements and domestic and international regulations as well as experience with running virtual and/or remote studies. - A few key cross functional teams you will work closely with are engineering design teams, data analysis, legal, business development, and other project management teams. Having exposure and familiarity with the changing dynamics of research and development is highly desired. - The Operation Studies Project Manager will be responsible for maintaining communication with test sites; ensuring study compliance to domestic / international regulations; maintaining project schedules; understanding and managing budgets; work with cross-functional teams, communicate well; creating meetings and documenting action items and progress; reporting and presenting to management on project status and schedules.

Education & Experience

- B.S. degree in biomedical engineering or any engineering field , or equivalent

Additional Requirements