Associate Director, Clinical Data Management

Role: Associate Director, Clinical Data Management, leading data activities for clinical trials at PTC Therapeutics. Primary objectives include ensuring accurate, consistent clinical database management, overseeing data collection, cleaning, reconciliation, and reporting, while supporting regulatory compliance and SOP development. Responsibilities encompass managing internal teams and external vendors, collaborating with clinical operations, biostatistics, and regulatory teams to design eCRFs, lead database development, supervise data review and lock processes, and optimize workflows for efficiency. Qualifications: Bachelor's in science or related field, minimum 8 years of relevant experience in pharma/biotech/CRO, with leadership in data management, vendor oversight, and clinical trial data operations. Skills include expertise in Medidata RAVE (EDC), relational databases, data standards (CDISC, 21 CFR Part 11), and regulatory guidelines (ICH, FDA). Preferred experience with PL/SQL, SAS, Java, C++, and data visualization tools. High-value specifics: Experience with clinical trial data in late-phase (Ph1-3), biologics or small molecules, with an emphasis on regulatory compliance, data standards, and cross-functional team leadership. Work setup: hybrid model in Warren, NJ, with 5-15% travel. Management responsibilities may extend to mentoring direct reports.