Studies Specialist, Health Technologies
3 Months ago • All levels • $118,500 PA - $197,500 PA
Job Description
The Health Technologies Group at Apple is seeking a Studies Specialist to support the development and validation of new health sensors and algorithms. This role involves capturing and organizing human study data, ensuring compliance with regulations, and synthesizing information for senior management. The specialist will manage Good Clinical Practice (GCP) requirements, create study documents like operational plans and informed consent forms, prioritize tasks with internal and external partners, and interact with cross-functional teams including IRB, clinical compliance, regulatory, quality assurance, engineering, data analysis, and legal. Responsibilities also include maintaining external site communication, tracking documentation, updating clinical SOPs, and ensuring study TMF readiness for audits.
Must Have:
- Capture and organize study data
- Understand regulatory requirements
- Synthesize and summarize data
- Manage GCP and audit readiness
- Create study-related documents
- Prioritize with internal/external teams
- Interact with multi-functional teams
- Maintain external site communication
- Develop/update clinical SOPs
- Maintain study TMF
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%.
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%.
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