
Strategic Quality Lead
2 days ago
As a Principal Central Monitor, you will play a strategic role in driving data integrity and operational excellence across clinical development programs through advanced centralized monitoring.
This position is responsible for developing and executing enterprise-wide strategies, leading risk assessments, and defining key performance indicators (KPIs) in collaboration with senior functional leaders.
Key responsibilities include:
- Designing and implementing comprehensive quality management plans tailored to each study's needs
- Conducting thorough risk assessments for clinical studies and developing mitigation strategies
- Interpreting complex data patterns, leading root cause analyses, and driving decision-making to enhance study quality and compliance
- Facilitating regular quality meetings to review and discuss study data, findings, and action plans
- Ensuring the highest standards of data quality and integrity through proactive monitoring and timely interventions
- Collaborating with clinical operations, data management, and other departments to support proactive oversight and management
Requirements:
- Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience
- Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent
- Working knowledge of ICH GCP guidelines and the clinical development process
Preferred qualifications include CRO experience as a Central Monitor and proficiency in statistical analysis and quality management tools.
Qualifications Summary: This is a critical leadership position that requires strong clinical expertise, strategic thinking, and excellent communication skills.
What We Offer: A dynamic work environment, opportunities for professional growth, and a chance to make a meaningful impact on the success of our clinical development programs.
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