Duration
2-3 months with likely extensions
Job Description
Pharmaceutical client needs a Sr. Manager of GCP for at least 2-3 months as a consultant with very likely extensions who has some experience with clinical operations, clinical trials and quality assurance to build out their GCP audit management program. Schedule, plan, implement, and track their audits. Work with the clinical operations, and research vendors at the CMO sites to plan the audit schedules and scopes. Having experience as a study coordinator or study monitor would be helpful in the role. Big focus is on audit management. There are currently 5-6 sites that need to be coordinated with and scheduled. Along with the auditing program this person needs to work on their SOP revision project. There are over 30 GCP and safety SOPS that need to go from their paper based system to their electronic system. Many of the SOPS require strong revision and many documents need formatting to be done. Having a good background with editing documents in MS Word is a must. All of this project is being tracked in Smartsheet. Person must work with the clinical, biostats, and operations teams to ensure documents are being tracked and are moving along and edits and revisions are being completed and are organized properly so having document control experience is helpful.
Skills
- GCP, Audit management, SOPs
Hybrid: GCP Consultant (234599)
