Clinical Data Manager
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Accentuate Staffing is recruiting for a Global Clinical Research Organization in Raleigh who is a seeking a Clinical Data Manager to join their growing team. This role will serve as the primary Clinical Data Management contact with sponsors and represents CDM on project teams.
Please email resumes to laura@accentuatestaffing.com
Responsibilities:
- Direct activity of CDM team members to complete project deliverables on schedule according to quality standards, requirements, and project budget from study start-up through archival
- Develop and maintain CDM study files; Identify all internal and sponsor CDM deliverables contracted in scope of work and establish time estimates; Specify data cleaning guidelines, conventions, Global Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements
- Maintain consistent, manageable workflow for CDM project team by monitoring enrollment information and communicating with project team to actively influence data collection
- Maintain CDM project budget by identifying CDM activities outside scope of contracted work, obtaining agreement from sponsor or management prior to performing out-of-scope tasks, preparing or reviewing budget and cost analysis documentation routinely, and following scope issues through to resolution
- Develop project reports which meet needs of sponsors, project team, and management, are accurate, and are provided to sponsor and CDM management upon request or a re-arranged schedule
Requirements:
- 2 to 4 years of related Clinical Data Manager experience in either pharmaceutical or CRO environment and 2 years of relational database experience
- Bachelor’s degree in nursing or life science and/or equivalent combination of education and clinical research experience
- Experience with Medidata Rave or OmniComm TrialMaster
