Diane Ma

Clinical Project Manager at Neuralink
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Location
Seattle, Washington, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 200 - 300 Employee
    • Clinical Project Manager
      • 2018 - Present

      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… Show more 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

    • Clinical Trial Director
      • 2014 - 2018

      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… Show more 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

    • Clinical Research Physician
      • 2012 - 2014

      San Francisco, California, United States Understand the clinical trial process from start to finish Efficient collaboration with investigators, study center staff and Neuralink team members Working knowledge of FDA regulations related to clinical research Working knowledge of medical and scientific terminology Demonstrate communication skills Demonstrate problem-solving skills in leading clinical trial monitoring visits and demonstrate tact and diplomacy in communicating with investigators, participants, and study… Show more Understand the clinical trial process from start to finish Efficient collaboration with investigators, study center staff and Neuralink team members Working knowledge of FDA regulations related to clinical research Working knowledge of medical and scientific terminology Demonstrate communication skills Demonstrate problem-solving skills in leading clinical trial monitoring visits and demonstrate tact and diplomacy in communicating with investigators, participants, and study coordinators

    • Clinical Research Associate
      • 2010 - 2012

      San Francisco, California, United States Understand the clinical trial process from start to finish Efficient collaboration with investigators, study center staff and Neuralink team members Working knowledge of FDA regulations related to clinical research Working knowledge of medical and scientific terminology Demonstrate communication skills

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Education

  • Harvard University
    Master's degree, Neuroscience

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