Studies Project Manager, Health

Santa Clara Valley (Cupertino), California, United States
Software and Services

Summary

Posted:
Weekly Hours: 40
Role Number:200441710
The Health Group conceives of and proves out exciting new technologies for Apple’s future products and features. We are seeking a Studies Project Manager to lead human study efforts in collecting data to support development and validation of new health sensors and algorithms.

Key Qualifications

  • 5-7+ years of project management experience
  • Strong human research background with clear understanding of study lifecycle
  • Experience working with and handling external sites and/or managing vendors
  • Strong organizational and leadership skills with a track record of timely project delivery
  • Experience running virtual and/or remote studies and knowledge on conducting clinical studies with Hardware/Software devices
  • Strong problem solving skills and critical thinking
  • Experience in budgeting and financial forecasting at a project/study level

Description

Studies Project Managers are responsible for leading the study strategy and execution, presenting on study milestones and schedule internally and with external partners. A project manager will prioritize issues and track the details, as well as be in touch with the larger picture. This must be confident organizers who work with the highly skilled internal hardware and software design teams and external teams to achieve successful study meeting timelines and data quality needs. The Studies Project Manager needs to have a solid understanding of human studies research lifecycle, strong knowledge of domestic and international regulations, experience with running virtual and/or remote studies and experience handling study budget. Finally, this person needs to be adaptable to leading studies with varying levels of data collection requirements. We are looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to changes. Multi-functional communication skills and experience are essential. This person will interact with all engineering design disciplines, 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 Studies Project Manager will establish strategy and maintain communication with external test sites; ensure study compliance to domestic/international regulations; maintain project timelines; understand and manage budgets; multi-functional organization, communication, and management; create meetings and document action items and progress; report and present to senior management on project status and schedules.

Education & Experience

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

Additional Requirements

  • - Thrive in a fast-paced environment
  • - Ability to adapt, improve, and influence teams to embrac best practices
  • - Knowledge of domestic and International regulations
  • - Self-motivated and proactive with critical thinking and resourcefulness to drive the project to success
  • - Excellent communication skills, both verbal and written
  • - Experience with performing audits with various regulatory agencies a plus
  • - Some travel is required, approximately 15-20%

Pay & Benefits