Senior Centralized Study Coordinator

Summary of Responsibilities:

• Follow all applicable departmental Standard Operating Procedures and Work Instructions.
• Complete day-to-day tasks ensuring quality and productivity.
• Track and report metrics as determined by management according to required timelines.
• Participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
• Other duties/activities as assigned by study management team, but not limited to:
  • Manage clinical systems & access management
  • Manage study documents such as study level, country level and site level
  • Maintain study databases (CTMS, IWRS, EDC etc.)
  • Support study team in e-TMF management activities
  • Support study team in data review and support activities.
• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
• Address all outstanding issues for sites and provide a snapshot of issues to Clinical team including CRA’s to make the site visits more effective and efficient.
• 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.
• Work with Study Team to maintain WISER moments.
• May assist with additional cross-functional tasks according to project needs.
• Initiates RIM changes, manages PCC Log, and supports documentation and impact tracking.
• Assists in vendor management activities including invoice tracker and PO requisitions.
• Handles PII assessments, system documentation, and updates to XRIM as needed

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.

Learn more about our EEO & Accommodations request here.