Clin Ops Delivery Associate I

hace 5 meses

Lima, Perú Thermo Fisher Scientific A tiempo completo

According to the specific role (Central or Local), coordinates, oversees and
- completes functions on assigned trials activities detailed on the task matrix.- Performs department, Internal, Country and Investigator file reviews as assigned

and documents findings in appropriate system.- Ensures allocated tasks are performed on time, within budget and to a high

quality standard. Proactively communicates any risks to project leads.- Supports the maintenance of study specific documentation and systems including

but not limited to: study team lists, tracking of project specific training
- requirements, system access management, and tracking of project level activity
- plans in appropriate system.- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials including but not limited to:
timely processing of documents sent to Client (e)TMF as assigned, performing
- (e)TMF reviews, performing mass mailings and communications as needed,
- providing documents and reports to internal team members.- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with

clarification and resolution of findings related to site documentation.- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File

(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.- Assists with study-specific translation materials and translation QC upon request.

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