Project Mgr

Thousand Oaks, California | Contract

Post Date: 02/03/2015 Job ID: 412

Top 3 skill sets
1. 7+ years experience in clinical data management in the pharmaceuticals/biotechnology setting with CRO oversight
2. Hands-on working knowledge / Experience with Electronic Data Capture (EDC) systems (RAVE ideal)
3. Ability to manage multiple projects at once.

Job Duties
  • Utilize extensive clinical data management experience in study start-up, conduct, and closeout to manage and participate in various projects within the global development process. 
  • Maintain project timelines and oversight of assigned tasks.

Responsibilities

  • Oversee a lead data manager working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
  • Ensure that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
  • Accountability for meeting study/project timelines.
  • Lead CDM activities for assigned project team.
  • Communication within their assigned product teams globally and cross-functionally.
  • Review of all study related documents within a project area, ensuring consistency and accuracy of content.
  • CDM representation on assigned project teams e.g. Global Clinical Study Team.
  • Support electronic submission activities. Critical to have hyperlinking & submission management experience, including experience with publishing software (i.e. Adobe Professional) and Inspection Readiness activities in support of filing activities.
  • Promote and be an advocate of CDM internally and externally

?Skills

  • Extensive experience in clinical data management activities within the biotechnology or pharmaceutical industry and to apply the general processes to assigned process improvement activities. 
  • Direct oversight experience is required and intimate knowledge of data management study start-up, maintenance and closeout is essential.
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