Key Accountabilities:

Trial and Site Administration

•Assistsin coordination and administration of clinical studies from the start-up to execution and closeout.

• Serves as local administrative main contact and works closely with the CRAs and/or the Local Study Associate Director (LSAD) for the duration of the study.

• Sets-up, populates and accuratelymaintainsinformation in Client tracking and communication tools (e.g.CTMS such as VCV, SharePoint, etc.) and supports others in the usage of these systems (except for countries where there is a specific role dedicated tosetup andupdatethe systems).

• Manages and contributes to coordination and tracking of study materials and equipment. 

• Coordinates administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs.

• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings.o Liaiseswith internal and external participants and/or vendors, in line with international and local codes.

• Prepares, contributes to, and distributes presentation material for meetings, newsletters, and websites. 

Document Management

• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.

• Operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (ISF) including document trackingin accordance withICH-GCP and local requirements.

• Ensures essential documents under their responsibility are uploadedin a timely mannertomaintainthe eTMF “Inspection Readiness”.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.

• Contributes to the production and maintenance of study documents, ensuring template and version compliance.

• Responsible for layout and language control,copyingand distribution of documents. Supports with local translation and spell checks in English to/from local language, asrequired.

• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related emails.

• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives tofacilitatethe delivery of study related documents/material. 

Regulatory and Site Start Up Responsibilities

• Collects,assistsin preparation, reviews, and tracks documents for the application process.

•Assistsintimelysubmission of proper application/documents to EC/IRB and, whereappropriate toRegulatory Authorities for the duration of the study.

• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g.ANGEL) ensuring compliance with the Client’s Authoring Guide for Regulatory Documents.

• Contributes to electronic applications/submissions by handlingclinicalregulatorydocuments according to the requested technicalstandardsi.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities. 

Budgeting, Agreements and Payments

• Prepares and/or supports contract preparation at a site level (except for countries where there is a specific role dedicated to preparing site contracts).

• Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) paymentsin accordance withlocal regulations.