Director, Clinical Data Management
$200.7k - $252.6kPTC Therapeutics Inc
PTC Therapeutics seeks a Director of Clinical Data Management to lead strategic and operational oversight of clinical database quality, integrity, and regulatory readiness. The role involves cross-functional leadership, vendor management, and direct responsibility for data management processes across clinical trials.
Responsibilities
- Provide strategic oversight of clinical database quality, integrity, and inspection readiness
- Lead CRO oversight and manage data management plans from initiation through completion
- Partner with clinical operations, biostatisticians, and programmers to design data collection instruments
- Oversee adverse event coding, medical history review, and database cleaning activities
- Develop and update standard operating procedures and best practices documentation
Requirements
- Bachelor's degree in science or healthcare-related field
- Minimum 10 years progressive experience in pharma, biotech, CRO, or regulatory agency
- Proven track record leading data management teams
- Experience with IWRS, imaging, ePRO/eCOA, and database technologies
- Strong attention to detail and ability to manage multiple priorities
- Knowledge of regulatory compliance and clinical trial data standards
$163.8k - $206.2k
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