Act as the Lead DM on assigned studies, providing oversight of the CRO and owning all aspects of the study lifecycle as it relates to Data Management. Standardizes and manages the clinical data flow process to data delivery for analysis purposes. Be the main point of contact for the CRO and in house team, communicating and managing timelines effectively ensuring work is completed on time and at high quality. Ensure data quality in support of clinical study data milestones and deliverables. Interacts and manages relationships with other functional areas to ensure high quality data management activities.
8-10 years working in clinical data management and specific experience working for small to midsize pharma/biotech companies (must have direct sponsor). Must have experience with outsourced CRO oversight experience. Experience as a Lead DM for Phase II and Phase III studies within the last 3-5 years, with the willingness to work hands-on. Expertise with Medidata RAVE. Strong communication and organization to manage DM timelines, deliverables etc.
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