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Director, Clinical Data Management, Gene Therapy

Company: bluebird bio
Location: Cambridge
Posted on: June 23, 2018

Job Description:

Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. bluebird bio's growing Clinical Development Operations team is setting the standard for trial design, conduct, and analysis in gene therapy across multiple therapeutic areas. This is not your typical development operations role --- come make your mark with us! Reporting to our Head of Clinical Data Management you will be responsible for managing a team of Clinical Data Managers and for providing support for all aspects of Clinical Data Management for EDC trials managed in house and outsourced to Clinical Research Organizations (CROs). About the role: Oversee all day-to-day data management activities, timelines and deliverables for in house data management as well as outsourced services. Facilitate effective planning and execution of all the data management tasks. Ensure timeliness and quality of data deliverables in collaboration with other functions. Ensure compliance with global regulatory requirements and quality standards. Enable consistent data management approaches across Therapeutic Areas through adoption standards and best practices. Develop senior level DM program leads to advance leadership and project management skillset through training, mentorship, and career development coaching. Further enhance team's clinical and technical expertise and business acumen. Facilitate resource forecasting and allocation. Grow and scale a strong data management team. Enable high performance, mentorship, and career development for the team members. Participate in initiatives around process development, standardization, and technology May serve as a CDM study lead or program lead. May work with database programmers to develop EDC databases, edit checks and reports. Responsible for management and development for clinical data management staff. Select and provide oversight of third-party vendors and data management CROs Establish strong relationships with data management vendors to enable optimal outcomes. YourMembership_RPM.Category: Healthcare, Keywords: Healthcare Information Services Director

Keywords: bluebird bio, Warwick, Director, Clinical Data Management, Gene Therapy, Executive, Cambridge, Rhode Island

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