Job description
Associate Director, Data Management in Waltham MA. Oversee data management and back-end activities supporting clinical programs; manage relationships & establish partnerships with CROs, vendors, & external partners; oversee performance of data management vendors; oversee development/validation of clinical trial databases in accordance with ICH/GCP guidelines; define/implement eCRF standards (CDASH), data capture conventions, and CDISC compliant output; work with Statistics & Programming to ensure high quality data output; develop/report on data management performance metrics; lead computer system development initiatives; work with Clinical Operations to implement data management outsourcing strategy; provide supervisory leadership & training to Data Managers; conduct performance evaluations. Reqs: at least Bach in Comp Sci, Biotechnology, Healthcare, or equiv; 10 yrs exp in data management in a pharmaceutical/biotech or CRO setting, including 2 yrs in leadership role; knowledge of RECIST, iRECIST, CTCAE, local lab handling, databases, EDC platforms, data imports/integrations, SAS and/or SQL programming, GCP/ICH standards, 21 CFR Part 11. By resume to careers@alkermes.com.
Degree LevelBachelor's Degree
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