Project Management Coordinator Job

PROJECT MANAGEMENT COORDINATOR needed for a CONTRACT opportunity with Yoh's client located in Thousand Oaks, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Clinical trial adjudication support experience
- Project management, clinical trials industry knowledge/background
- Share Point knowledge
- Clinical trial tracking experience

WHAT YOU'LL BE DOING:

- Adjudication Operational Support
- Processing clinical trial and post marketing adjudication for all denosumab/Prolia/XGEVA and a subset of studies
- Coordinates and mails packages to clinical trial sites, tracks, follows up to ensure receipt of case forms and source documentation
- Coordinates and mails packages to clinical trial adjudicators for adjudication.
- Tracks, follows up and responds to any questions to ensure receipt of final adjudication decision
- Communicates final decision to CDM for entry into the CTDB (Rave, Oracle)
- Review weekly reports of negatively adjudicated endpoints and communicated with DSS Triage for updates to Narrative as appropriate.
- Tracks ONJ ONC Registry cases for regulatory reporting
- Process Atypical Femoral Fx Adjudication Cases
- Prolia Active Safety Surveillance Program (Core team metrics, FDA Assessment Reports, Awareness Survey, Quarterly Reminders, Protocol and material updates, DMP, IRPC)
- Manages MSRT MAC submissions
- Updates and maintains MSRT SharePoint sites- multiple
- Receives and reviews reports showing cases processed in prior month from Argus, randomizes and assigns 10% for QA assessment twice a month, ensures data collection for QA Program

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree
- Pharmaceutical clinical trial knowledge/experience
- Strong computer skills

WHAT YOU'LL BE DOING:

This is your opportunity to work for one of the leading consumer goods companies located in Thousand Oaks, CA.

OPPORTUNITY IS CALLING, APPLY NOW!

Yoh, a DayJ2W: SCIENTIFIC

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