Summary

Posted: Dec 3, 2020

Weekly Hours: 40

Role Number:200203665

The Health Technologies Group conceives of and proves out exciting new technologies for Apple's future products ...Summary

Summary

Posted: Dec 3, 2020

Weekly Hours: 40

Role Number:200203665

The Health Technologies Group conceives of and proves out exciting new technologies for Apple's future products and features. We are seeking a Studies Specialist to maintain our high standards with human study data collection efforts to support development and validation of new health sensors and algorithms.

Key Qualifications

• 5-7+ years of project management or clinical research associate experience
• Strong human research background with clear understanding of study lifecycle
• Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations, standards, and guidance
• Highly organized and hyper-attentive to detail
• Thrive in a fast-paced environment
• Ability to adapt, improve, and champion best practices
• Self-motivated and proactive with the critical thinking and resourcefulness to achieve study objectives
• Excellent communication skills, both verbal and written
• Experience working with and managing external sites and/or managing vendors
• Some travel is required, approximately 15-20%
• Experience in R&D or consumer product development a plus

Studies Specialists are responsible for capturing and organizing key information from studies with the ability to synthesize and summarize the data for delivery to Study Project Managers and senior management. Studies Specialists must excel at multi-tasking while maintaining high quality studies with external sites and vendors.

The SPS should have knowledge of Global GCP requirements and how they apply to the execution of studies.

Studies Specialists are key to managing the details required for a successful study, from understanding regulations requirements and how those apply to the study, to managing equipment and tracking to data quality monitoring. They love to maintain change control, adjusting the level of change control required depending on the needs for the study.

Studies Specialists must be able to prioritize and be proactive with internal engineering development teams and external sites and vendors to achieve success with delivering high quality data on time.

We are looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to changes. Cross-functional communication skills and experience are essential. The Studies Specialist 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 Specialist will be responsible for maintaining communication with external test sites, tracking delivery and change control of documentation, tracking progress against budgets, and communication with internal cross-functional teams.

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

Additional Requirements