Sr. Director, Head Of Clinical Monitoring And Operational Systems

MapLight Therapeutics, Inc.

Remote, US
Base: $270,000 - $300,000 usd; bonus/equity: annua...
Remote
12 years in clinical trial industry
5 years onsite clinical monitoring experience
5 years global trial monitoring oversight
MapLight Therapeutics is seeking a Sr. Director, Head of Clinical Monitoring and Operational Systems to oversee global clinical monitoring and operational systems for its clinical trial portfolio. The ideal candidate will have extensive experience in clinical trials, including direct management of monitoring teams and a strong understanding of regulatory standards

Job Summary

  • The role involves strategic development and execution of global clinical monitoring across the entire clinical trial portfolio for central nervous system disorders.
  • Candidates must oversee Lead CRAs, manage external CRO partners, and ensure high standards of quality and consistency in compliance with GCP regulations.
  • The position offers a competitive salary range of $270,000 to $300,000 USD along with comprehensive benefits including stock options and parental leave.

Matching Summary

Match Score: 85

MapLight Therapeutics is seeking a Sr. Director, Head of Clinical Monitoring and Operational Systems to oversee global clinical monitoring and operational systems for its clinical trial portfolio. The ideal candidate will have extensive experience in clinical trials, including direct management of monitoring teams and a strong understanding of regulatory standards.

Salary

Base: $270,000 - $300,000 USD; Bonus/Equity: Annual bonus opportunity and stock options; Benefits: Medical, dental, vision, life, AD&D, disability, 401(K) match, PTO, parental leave

Skills & Requirements

Must-have

  • 12 years in clinical trial industry
  • 5 years onsite clinical monitoring experience
  • 5 years global trial monitoring oversight
  • Experience managing FSP/CRO teams
  • Deep knowledge of ICH-GCP FDA EMA regulations
  • Proficiency with CTMS and eTMF platforms

Nice-to-have

  • Competency in Power BI for efficiency
  • Passion for positive site relationships
  • Ability to lead a collaborative team
  • Strong presentation and communication skills
  • Willingness to teach and mentor others

Key Requirements

  • Bachelor's degree in relevant field
  • Minimum 12 years clinical trial industry experience
  • Minimum 5 years direct management of monitors
  • Ability to travel up to 30% annually

Work Rights

Not specified

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