该职位来源于猎聘
- Support to local study team (CRAs/CLM) o Assistance in tracking of documents (e.g. CA, financial agreements, contact cards, diaries, insurance certificates) o Assistance in preparation of submission package to ECs/HA (initial, substantial amendments, DETF, CSR) and submission to EC/CAs o Circulate and distribute Investigator brochures and track accordingly o Maintenance of (basic) correspondence with Global Study Team (e.g. SLM/StM), site personnel o Support and maintain constructive relationships with external partners (e.g. investigators, study coordinators, CROs) and internal partners (e.g. RA, Legal, PV, Import/Export Dept., Controlling, Finance) o Logistic management of non-drug study related supplies/services o Support in local study process, presentations, mailing to sites, local personnel, newsletters and correspondence. o Assistance in preparation, support during conduct of audits and inspections of study documents o Perform and/or coordinate translations of study documents o Initiate the order of equipment for office staff (e.g. IT-equipment, office supplies o May accompany CRAs/CLMs to investigator sites
- Processing of invoices and tracking of study budgets o Process study-related invoices, reimbursements and track payments from or to internal or external service providers and enter information into tracking system, if required. o Ensure that all relevant documentation of invoices and payments is filed in the TMF
- Organization and support of meetings (incl. TCs) o Support and/or attend and follow-up of local team meetings and local investigator meetings (e.g. attendee list, agenda, compilation of materials for the meeting, writing of minutes, if applicable) o Logistic of the attendance of site staff to the investigators' meeting: invitations, travel organization, reimbursement of expenses, etc.
- Organization and booking of business trips o Logistics and booking of business trips, accommodation and transfers for local and global study team, study related consultants and investigators o Organization of transfer requirements, rental cars, travel visa
- Set-up and/or maintenance of appropriate databases and other IT related tasks o Maintenance of databases (e.g. CRM, Impact, SharePoint, eRoom, study web, eDiary) o Update of appropriate local law or local regulatory databases o Set-up of study tracking tools o May function as Local Code Administrator (LCA), superuser, or data entry for IMPACT o Support in different SAP-tools, computer systems
- Set-up, maintenance, preparation for archiving and QC checks of the TMF o Set-up of TMF files (StF, CF, SSIF) and in-house filing of TMF documents in the appropriate files according to the SOP and ICH-GCP and other local guidelines, and ongoing file maintenance during the study to support readiness for audits and inspections o Set-up and distribution of Investigator Site Files and support CLM in conduct of QC checks o Prepare and update specific tracking overviews (e.g. MS-Excel spreadsheet, MS-Word table) on request by CRAICLM, e.g. for follow-up of document collection for EC-submission assembly, overview of drug safety documentation, disclosure agreements, contracts, contacts sites il necessary, etc. o Preparing in-house/out-sourced TMF files for sending to respective GRA Archive: Study File, Country File, Sponsor Site Files and request documents from other functional areas o Review, tracking and completion of checklists for TMFs/Country File, and send it to responsible person for Final Quality check o Organizes archiving of Investigator Sites Files to the independent third party company, in case that the investigator asks for support when site cannot keep files in a longer term.
- Support to RHMSM, LHMSM and LM o Organization of business trips o Organization of (local, regional and global) meetings and trainings, o Preparation of presentations o General tasks (filing, preparation and forwarding of mailings, providing office equipment, preparing purchase orders) o Organization of mobile phones, blackberries, business cards o Prepare and initiate new starter process of all new members of GCO and StM team
- Support in study drug related tasks o Support in study drug logistic management o For drugs returned to sponsor -Order packing materials for disposal (forms, containers, labels), prepare and coordinate transfer of drugs to the Waste Disposal Department/Location for destruction.