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US: Lead Clinical Data Manager

Date: 11-Jun-2015
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Lead Clinical Data Manager

PRIMARY ROLE The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. May mentors team members and more junior staff and may direct activities of contract Data Manager staff.

7 years as a Sr. Data Manager within a Data Management organization Experience with leading teams and/or organizations.

CCDM certification preferred


Must be able to produce data management reports Strong attention to detail and accuracy is a must. Ability to read, analyze and interpret complex technical documents. Ability to present complex issues in oral and written form. Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook. Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community. Proven ability to manage and communicate effectively with research vendors including reviewing request for proposals, analyzing scope of work, budgeting and forecasting, responding to inquiries and complaints. Demonstrated ability to prioritize across work assignments.

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BioTech FYI Center