Study Oversight
The Project Management of GCP-Service ensures all involved parties are fully informed of and adhering study requirements by overseeing timelines, task assignments, and maintaining budgets.
Services GCP-Service Projects Managers offer:
- Serve as the sponsor’s main contact
- Liaison between sponsor, project teams, and vendors
- Organization of project plans (e.g. Communication Plan, Project Management Plan, Quality Risk Management Plan, Statistical Analysis Plan, etc.)
- Organization of set-up of electronic tools (CTMS, eTMF, eISF, EDC, IRT, ePRO, Safety Database, etc.)
- Team communication and coordination meet to study timelines
- Development of project specific processes
- Coordination and team members training on study specific tasks, protocol, SOPs, plans
- Study budget control and investigator fee invoice management