CDM Support Coordinator

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Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix. Performs department, Internal, Country and Investigator…...

  • Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
  • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Follows up for resolution of findings and escalates whenever necessary.
  • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity (in case involved in a Lead role).
  • Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers including, but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.
  • Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents, maintaining audit readiness and communicating the non-compliance to the study team and suggesting resolution.
  • Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRGs/Client eTMF as required, performing CRGs/Client eTMF reviews and coordinating and proposing issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes and follow up for closure of action items, if required.
  • Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role.
  • Maintains and regularly checks for correctness of vendor trackers.
  • Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
  • Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.

Information :

  • Company : Thermo Fisher Scientific
  • Position : CDM Support Coordinator
  • Location : Work from Home
  • Country : PH

How to Submit an Application:

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Post Date : 31-05-2024