Follow all applicable departmental Standard Operating Procedures and Work Instructions.
Complete day-to-day tasks ensuring quality and productivity.
Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
Track and report metrics as determined by management according to required timelines. Proactively identify opportunities for process improvements and participate in implementation.
Ability 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
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
Assist in study payments (Site and Vendor)
Document and track study activities using relevant forms and tools, as we'll as relevant Project Management Systems with guidance/support; including data related to Clinical, SU, and VM.
Centralized Study Spec I are expected to take a leadership role in ensuring a successful partnership with other support groups, Centralized Study Spec I are expected to help remove barriers and to facilitate success.
Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
May serve as the Centralized Study Spec I on projects where there is more than one Centralized Delivery Associate or Sr Centralized Delivery Associate (provide guidance, facilitate teleconferences, task review, task delegation)
Actively support compliance metrics including TMF, CTMS, and overall project health
Update timelines and milestones within MS Project, CTMS, project governance tool, and other trackers which may include updates for applicable functions. Escalate when timelines are at risk.
Can draft or assist Project Lead / FL with project plans and coordinating review, feedback, and execution between study team (functional leads) and client
May assist with additional cross-functional tasks according to project needs
Can draft or assist Project Lead / FL with project plans and coordinating review, feedback, and execution between study team (functional leads) and client
May assist with additional cross-functional tasks according to project needs
Update timelines and milestones within MS Project, CTMS, project governance tool, and other trackers which may include updates for applicable functions. Escalate when timelines are at risk.
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 Management oversight
