- Follow all applicable departmental Standard Operating Procedures and Work Instructions.
- Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
- Support implementation of new monitoring tools
- Track and report metrics as determined by management according to required timelines.
- Proactively identify opportunities for process improvements and participate in implementation.
- Able to mentor and train others.
Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems
- Manage study documents and support eTMF management
- Support study teams to resolve data management queries
- Maintain study databases (CTMS, IWRS, EDC etc)
- Track and follow up with CRAs for outstanding issues
- Support in generating the study specific reports.
- Manage internal/external communications
- Assist in ensuring training compliance for study teams
- Manage study payments (Site and Vendor) - Ex: Payment reconciliation and release
- Review study performance dashboard
- Document and track study activities using relevant forms and tools, as we'll as relevant Project Management Systems with guidance/support.
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
- Actively support compliance metrics including TMF, CTMS, and overall project health.
- Update timelines and milestones within project scheduling tools, CTMS, project governance tool, and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk.
- Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations.
- Draft or assist Functional Leads with project plans and coordinating review, feedback, and execution between study team and client.
- May assist with additional cross-functional tasks according to project needs.
Additional responsibilities (Centralized study team may perform below activities)
- Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed.
- Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements
- Vendor Oversight Management
