Associate Director Clinical, Data Management
$162,000–$190,000 year
Hybrid · Rockville, Maryland, United States
Job Summary
Senior-level leadership role overseeing the Clinical Data Management team within Clinical Development. Responsibilities include developing and maintaining data management processes and SOPs, establishing data capture, management, and review standards to ensure data quality and regulatory compliance, providing consultation to Clinical Development teams, maintaining timelines and metrics, vendor management, supervising data management staff, coordinating UAT and EDC databases, developing DTAs, overseeing Case Report Forms development, reviewing clinical documents, coordinating study-database archiving, writing SOPs, and driving continuous process improvements. Requires strong leadership and management experience, expertise in EDC, familiarity with CDISC/SDTM/CDASH, regulatory knowledge (FDA, Health Canada, ICH GCP), and ability to work both independently and in a team. Authorized to work in the United States without visa sponsorship. Salary range $162,000–$190,000 plus benefits.
Required Qualifications
- Master’s degree with at least 9 years OR Bachelor’s degree with at least 11 years of experience in clinical and/or operational data analytics.
- At least 5 years of personnel management and project team leadership experience.
- Working knowledge of database applications.
- Proficient with EDC technology.
- Working knowledge of industry standards such as CDISC, SDTM, CDASH.
- Experience in CNS is preferred.
- Data Management Certification a plus.
- Budget forecasting/management a plus.
- Understanding of regulations governing clinical research (i.e., FDA, Health Canada), and ICH GCP guidelines.
- Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel.
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