Clinical Study Administartor (CSA)
TFS, Sweden

Clinical Study Administrator (CSA)

WHY JOIN TFS?

With our fully outsourced positions, the successful candidate will enjoy the best of both worlds: The workplace benefits of a top pharma company, and the support and advocacy of TFS - always working in our employee's best interest.

Responsibilities

• Assist in coordination and administration of clinical studies from the start-up to execution and close-out.
• Collect, assist in preparation, review and tracking of documents for the application process (HA/IEC). Interface with Investigators, external service provider, CRAs and lead CRAs during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs, lead CRAs and/or the LSM until finalization of the study.
• Operational responsibility to set-up the local trial master file (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) confirming International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRAs in the maintenance and close out activities for the ISF.
• Contribute to the production and maintenance of study documents, confirming template and version compliance. Translate or give the appropriate support with the translation of documents when required.
• Create and/or import clinical-regulatory documents into the global electronic library (GEL) according to the global document list (GDL) verifying compliance with the AZ authoring guide for regulatory documents to support publishing in GEL.
  
• Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. submission ready standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Set-up, populate and accurately maintain information in AZ tracking and communication tools (e.g. CTMS, SharePoint etc) and support others in the usage of these systems.
• Contractual support of study delivery suggests appropriate payment by investigator and supports in negotiations with sites and investigators.
• Verifies HCP payments are made in compliance to regulations.
• Manage and contribute to coordination and tracking of study materials and equipment.
• Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
• Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors.
• Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites.
• Responsible for layout and language control, copying and distribution of documents. Support with local translation in Sweden and spell checks in English to/from Swedish.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study related e-mails.
• Interface with data management centre and/or data management enablement representatives to facilitate the delivery of study related documents (global studies).
• Additional country-specific tasks depending on country need.

Job Rewards and Benefits