CLINICAL DATA MANAGER
Permanent/CRO
JOB PURPOSE / SUMMARY
Serve as primary Clinical Data Management (CDM) contact with sponsors and represents CDM on company project teams.
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 company 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 company management, are accurate, and are provided to sponsor and CDM management upon request or a re-arranged schedule
QUALIFICATIONS
- 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
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