Director, Data Management

Role: Director of Data Management at uniQure, responsible for leading end-to-end Data Management activities across multiple clinical programs, overseeing CRO vendors, and developing the function strategically and operationally. Objectives include ensuring high-quality data deliverables, compliance with regulatory standards, and optimizing vendor performance. Responsibilities encompass serving as an internal SME, developing SOPs, managing audits and regulatory interactions, and handling budget planning and vendor selection. Required qualifications include an advanced degree in life sciences, data science, or biostatistics, with 10+ years of experience in clinical Data Management within biotech or pharma. Expertise in clinical database design, CDISC standards (SDTM, ADaM), and SAS technical skills is essential. Deep understanding of the clinical trial process, lifecycle, and regulatory engagement is necessary. Preferred skills include leadership and communication capabilities. High-value specifics involve clinical development knowledge in biotech/pharma, regulatory interactions, and GxP compliance. The role collaborates closely with Biostatistics, Clinical Operations, Medical, and other clinical functions, based in Lexington, MA, with a focus on internal and external vendor management.