
Clinical Development Strategist
6 days ago
This is a senior leadership position responsible for driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management.
The successful candidate will lead the development of robust quality management plans in collaboration with cross-functional teams to design and implement comprehensive strategies.
- Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
- Design and oversee the implementation of advanced centralized statistical monitoring frameworks, interpreting complex data patterns, leading root cause analyses, and driving data-driven decision-making.
- Facilitate regular review meetings to discuss study data, findings, action plans, and coordinate data cleaning activities.
- Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
- Minimum 8 years of experience in clinical monitoring, clinical trial management, or equivalent.
- Working knowledge of ICH GCP guidelines and the clinical development process.
- Statistical analysis and data monitoring.
- Risk assessment and mitigation.
- Report writing and presentation.
- Collaboration and teamwork.
We are an Equal Opportunity Employer. We make employment decisions without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.
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