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Clinical Data Manager

  • Location: Houston
  • £ Salary: Negotiable per year
  • Job Type:Permanent

Posted over 2 years ago

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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