Studies Specialist, Health Technologies

Our ever-evolving suite of health and wellness products are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found it. 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.

Studies Specialists are responsible for capturing and organizing key information with a focus on understanding regulations requirements, how those apply to the study and the ability to synthesize and summarize the data for delivery to senior management. Studies Specialists must excel at multi-tasking while maintaining high-quality studies with external sites and vendors. Studies Specialists are key to managing the Good Clinical Practice (GCP) and document details required for a successful study, from requirements, to planning and implementing a strategic plan for GCP compliance and audit readiness. Some of the key responsibilities include: • Create, develop, review, and finalize study related documents such as operational plans, informed consent forms, etc. • Prioritize and be proactive with internal engineering development teams and external partners to achieve success with delivering data on time. • Interact with multi-functional teams, such as IRB, internal IRB, clinical compliance teams, regulatory and quality assurance teams, engineering design disciplines, data analysis, legal, and other project management teams. • Responsible for maintaining communication with external sites, tracking delivery and change control of documentation, and communication with internal collaborators. • Develop, update, and maintain clinical SOPs. • Maintain study TMF and ensure audit readiness. This is a site-based role. Some travel is required, approximately 15-20%.