In-region Study Manager
Summary
The Health Group conceives of and proves out exciting new technologies for Apple’s future health and wellness products and features. We are seeking a Studies Manager to lead human study efforts in collecting data critical to the development and validation of new health sensors and algorithms. Our team works in a highly dynamic environment to make the best products possible. If this sounds like you, read on!
Description
The Studies Manager is responsible for supporting study execution, communicating with internal and external teams/partners on study milestones and schedule. In addition, this Study Manager will have responsibility over study compliance to GCP and safety management. We are looking for someone who enjoys solving problems, is flexible, and responds quickly, energetically, and enthusiastically to changes.
Responsibilities
- Establish and maintain project schedules, prioritize issues and track the details as well as be in touch with the big picture
- Collect high quality data and ensure study compliance to domestic / international regulations
- Responsible for tracking study heath, prioritize issues and escalate as needed between local teams and US-based team
- Assist with the creation, development, review, and finalization of study related documents such as operational plans, informed consent forms, etc.
- Responsible for maintaining communication with external sites and/or CRO to ensure tracking and management of safety events and study monitoring
- Assisting in in-region regulatory team EPM activities
Minimum Qualifications
- Located or willing to re-locate to China; fluent in Chinese
- B.S. degree in biomedical engineering or any engineering field or equivalent
- Minimum of 5 years clinical study project management experience - candidates must have hands on experience providing support which includes: CRO collaboration, tracking regulatory documentation, study monitoring and safety event management. Have completed GCP training.
- Self-starter with the ability to establish priorities, facilitating actions, and work autonomously
- Good collaboration and communication skills — able to drive cross-functional deliverables and communicate in clear, concise and effective manner
- Highly organized with attention to detail — to ensure study success, the new hire must be capable of identifying operational and participant safety issues and to track solutions to completion
- Strong organizational and management skills with a track record of on-time project delivery
- Top-notch negotiation skills and adept at facilitating actions and resolving conflicts
- Able to thrive in a fast-paced environment
- Flexible and comfortable with ambiguity — able to rapidly optimize across many variables to problem solve and effectively guide decisions
- Experience in budgeting and financial forecasting at a program level
- Experience in executive level communications
- Some travel may be required, up to approximately 25%
Preferred Qualifications
- Experience in R&D or consumer product development a plus - familiarity with the changing dynamics of research and development will help you thrive in this role
Apple is an equal opportunity employer that is committed to inclusion and diversity, and thus we treat all applicants fairly and equally. Apple is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities.