
Senior Clinical Operations Manager
13 hours ago
As a seasoned professional, you will oversee all data management activities to ensure compliance with ICH-GCP and regulatory requirements. You will be responsible for maximizing effectiveness within scope, providing solutions for complex problems, and leading cross-functional teams for data reviews and CDISC standards guidance.
Key responsibilities include:
- Clinical Data Management Oversight: Ensuring compliance with ICH-GCP and company obligations.
- Problem-Solving & Expertise: Providing solutions for complex problems in clinical data management.
- Project Leadership: Overseeing large drug development programs and ensuring timely delivery.
- Regulatory Compliance: Applying expert knowledge of FDA and ICH regulations to data capture and management processes.
Required Skills & Qualifications
Requirements include:
- Data Management & Technology: Extensive experience in data management and the drug development process.
- Clinical Database: Strong knowledge of Clinical Database Programming Overview and study setup.
- CDISC Standards: Expert knowledge of CDISC standards and their application.
- Regulatory Knowledge: Deep understanding of FDA and ICH regulations.
- Clinical Trial Documents: Solid understanding of key clinical trial documents such as protocols, statistical analysis plans, CRFs, and study reports.
Benefits
This role offers:
- Minimum 8-10 years of total experience, at least 7 years in clinical data management and/or drug development.
- Experience with all phases of development and NDA/CTD submissions is preferred.
- Bachelor's degree in a health-related, life science area or technology-related field is mandatory, along with an MBA.
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