深圳招聘

FSP项目外派***Global Pharm
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
o 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.
任职条件：
1. Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with preferably experience in the healthcare field, pharmaceutical industry or clinical research.
2. Majored in Medical/pharmacological/Nursing/Science.
3. Understand GCP or has GCP certificate. Good GCP Sense!
4. Clinical Research experience on multinational pharma or CROs is a plus.
5. Fluent English in reading and writing. Good oral English is a plus.
6. Good communication skill, teamwork spirit, able to learn and adapt to IT system and scan equipment.
7. High motivation for the position and have clear picture of what this position will do.

深圳市翔安国际货运代理有限公司，是一家专门从事国际海运，空运和国际快递业务的物流企业。作为一家成熟的货代企业，公司认真负责，对客户无微不至，自成立以来，公司秉承“在服务中创造价值”的服务宗旨，谨奉“以诚为先，谋求共同发展；以人为本，追求完美服务”的经营理念，以热忱的服务态度、完善的服务功能、全新的整体规划、高效的服务体系以及良好的行业信誉赢得了市场的赞誉和社会各界的关爱；竭诚招募有识之士的加盟，共同发展，共创未来：
服务范围：
国际海运
国际空运
美国FBA、日本FBA
印度双清专线、孟加拉双清专线、阿根廷双清专线、菲律宾双清专线