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Head of Clinical Operations

Senseye, Inc.

Senseye, Inc.

Operations
Austin, TX, USA
Posted on Thursday, May 16, 2024

As the Head of Clinical at Senseye, you will be responsible for executing Senseye’s clinical strategy, enabling the development of our innovative mental health solution. Brining your expertise into collaboration with a stellar cross-functional team to empower Senseye on our mission to revolutionize mental health care.

Responsibilities:

  • Develop a deep understanding of the data needed from the perspective of all stakeholders to develop strategy and achieve synergies.
  • Successfully develop and execute on clinical strategy to enable model development and successful FDA and other global regulatory submissions.
  • Maintain the highest standards of clinical excellence and patient care. Create, implement, and maintain clinical best practices, SOPs, and standards for study management.
  • Stringent management and monitoring of clinical sites and the CRO.
  • Collaborate with the CRO to construct and update an actionable risk mitigation plan.
  • Develop clinical timelines and budget forecasts, tracking and delivering accordingly.
  • Ensure regulatory compliance and the timely preparation, review, and submission of clinical documentation.
  • Meticulously monitor and clean data prior to database lock, maintaining data integrity.
  • Establish an operational model for oversight, tracking, and escalation of issues within studies.
  • Continually evaluate the clinical program, implement optimizations, and adjust the roadmap as needed.
  • Manage and grow the clinical team
  • Experience with international trials or DCT a plus.
  • Experience in site selection and startup as well as study closeout