Senior Director, Head of Clinical Monitoring and Operational Systems
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Job Description
Sr. Director overseeing global clinical monitoring and operational systems at MapLight Therapeutics. Leading strategic development and execution across clinical trial portfolio with cross-functional teams.
Responsibilities:
- Ensure global clinical monitoring is executed with high standards of quality and consistency
- Oversee Lead CRAs and provide support and guidance for their management of monitoring teams
- Enhance the framework for clinical site monitoring and site management strategies
- Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems
- Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy
- Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs)
- Grow and develop team members in the clinical monitoring and operations systems team
- Represents the monitoring and clinical operations system functions in senior management meetings
Requirements:
- Bachelor’s degree in a relevant field
- a minimum of 12 years in the clinical trial industry with at least 5 years experience onsite clinical monitoring
- A minimum of 5 years providing global trial monitoring oversight with direct management of monitors
- Experience managing FSP/CRO monitoring teams and developing monitoring quality metrics, KPIs
- Demonstrated experience with a variety of CTMS and eTMF platforms
- Demonstrated ability to be versatile and serve as a role model
- Competency in technical systems that improve efficiencies (ex. Power BI)
- Demonstrates core understanding of medical terminology and clinical trial activities
- Deep working knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements
- Demonstrated ability to attend to detail and make effective presentations
- Ability to travel independently by air, car and/or train
Benefits:
- annual bonus opportunity
- medical, dental, vision, life and AD&D insurance
- short term and long term disability
- 401(K) plan with match
- stock options
- flexible non-accrual paid time off
- parental leave
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