Albert Mac Email & Phone Number

Pune, Maharashtra, India

San Francisco, California, United States

Project management and task management.Creation and review of clinical trial components, SOPs, participant-oriented materials, and study plans.Negotiating and building relationships with organizations.Management and oversight of external vendors.Implementation of clinical trials.Collaborate efficiently with external partners, clinical staff and Neuralink team.Organize study data collection pipeline.Maintain a working knowledge of and ensure compliance with good clinical practices, federal regulatory requirements, and site specific SOPs.

San Francisco, California, United States

Understanding of the clinical trial process from start to finish, including: experience managing key FDA interactions, trial site management, and working with CROs through the early feasibility and premarket/critical investigational device exemption (IDE) process.Experience with implantable Class II or Class III medical devices.Efficient collaboration with investigators, study center staff, and Neuralink team members.Experience and ability to work in an operating room environment.Working knowledge of FDA regulations as they relate to clinical research.Working knowledge of medical and scientific terminology.Demonstrate communication and management skills.Demonstrated problem-solving skills in managing clinical sites and demonstrated tact and diplomacy in communicating with investigators, participants, and study coordinators.