Centralized Study Associate I

To complete 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 Review: Upload, check, correct and maintain study documents for document review in the study eTMF regionally.

Send study documents for document review to eTMF archivist after release

Provide study documents for document review to the client as per study specific Investigator Package Plan

Perform tracking and data entry activities related to document review

Maintain and update document tracking information in CTMS and/or other tracking logs/systems

Perform administrative tasks required during the study (e.g. archiving, return files to client at end of the study)
- Study Support:
Generate Study Reports Perform Access management on applicable study systems Perform study system set up on new awarded studies CTMS compliance management Manage project communications Assist project teams for other study support activities

To follow all applicable departmental Standard Operating Procedures and Work Instructions. To complete required trainings according to required timelines. To complete day-to-day tasks ensuring quality and productivity. To maintain project and technical documentation in an appropriate manner. To perform checks to ensure quality of work completed To ensure timely escalation as needed. To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.To complete 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 Review: Upload, check, correct and maintain study documents for document review in the study eTMF regionally.

Send study documents for document review to eTMF archivist after release

Provide study documents for document review to the client as per study specific Investigator Package Plan

Perform tracking and data entry activities related to document review

Maintain and update document tracking information in CTMS and/or other tracking logs/systems

Perform administrative tasks required during the study (e.g. archiving, return files to client at end of the study)
- Study Support:
Generate Study Reports Perform Access management on applicable study systems Perform study system set up on new awarded studies CTMS compliance management Manage project communications Assist project teams for other study support activities

To follow all applicable departmental Standard Operating Procedures and Work Instructions. To complete required trainings according to required timelines. To complete day-to-day tasks ensuring quality and productivity. To maintain project and technical documentation in an appropriate manner. To perform checks to ensure quality of work completed To ensure timely escalation as needed. To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.To complete 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 Review: Upload, check, correct and maintain study documents for document review in the study eTMF regionally.

Send study documents for document review to eTMF archivist after release

Provide study documents for document review to the client as per study specific Investigator Package Plan

Perform tracking and data entry activities related to document review

Maintain and update document tracking information in CTMS and/or other tracking logs/systems

Perform administrative tasks required during the study (e.g. archiving, return files to client at end of the study)
- Study Support:
Generate Study Reports Perform Access management on applicable study systems Perform study system set up on new awarded studies CTMS compliance management Manage project communications Assist project teams for other study support activities

To follow all applicable departmental Standard Operating Procedures and Work Ins