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TMF专员 7-9k·13薪
大连-甘井子区 1-3年 本科
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带薪年假 五险一金
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宋女士 1天前在线 已认证
招聘专员 · IQVIA 艾昆纬
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职位介绍
Job Overview Provide Trial Master File (TMF)  related assistance to study teams.   Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices,  applicable regulatory requirements, and meets quality and timeline metrics. Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems. Essential Functions ● Perform assigned complex administrative tasks to support team members with project execution ● Assist in updating and maintaining complex data in systems within project timelines and per project plans ● Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines ● Conduct and manage scanning processes and train staff on scanning processes ● Interface with departments to support retrieval projects and ensure information needs are met ● Serve as primary contact for internal/external clients ● Monitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs) where applicable ● Maintain records center security to protect record integrity by ensuring compliance to SOPs ● May coordinate transfer, recall, and disposition of records to commercial records storage centers ● Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment ● Train team members on records management tasks, policies, and procedures ● Establish and maintain effective internal and external client communications ● Design and administer records management systems and processes ● Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs ● May function as team leader for records management projects Qualifications ● High School Diploma or equivalent  Req ● 3-4 years' experience working in revelant clinical research environment. Equivalent combination of education, training and experience. ● Good knowledge of applicable clinical research regulatory requirements; i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines; ● Knowledge of technology applications relevant to records center environments. ● General knowledge of computer technology and software programs, and accurate data entry skills. ● Attention to detail and accuracy in work. ● Ability to achieve productivity despite time pressure constraints. ● Good problem solving skills. ● Strong organizational, planning, and decision making skills. ● Good time management and prioritization skills. ● Extensive knowledge of records management laws and regulations. ● Excellent oral and written communication skills including good command of English language. ● Ability to manage and lead others. ● Ability to establish and maintain effective working relationships with internal and external clients. ● Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time. ● Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms. ● Position is required to stoop, kneel and may need to utilize a ladder for paper files on high-density file systems. ● Unaided lifting of objects up to 40 pounds/18kgs. ● May require to work in shifts.
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公司简介

IQVIA(纽交所代码:IQV)是全球专注生命科学领域的高阶分析、技术解决方案和临床研究服务供应商。IQVIA利用深入分析、前沿技术、大数据资源和广泛领域的专业知识,智能连接医疗生态的各个环节。IQVIA Connected Intelligence™快速敏锐地为客户提供强大的数据洞察,帮助客户加速创新医疗的临床开发和商业化进程,以更好的医疗成果惠及患者。IQVIA拥有约72,000名员工,足迹遍布100多个国家/地区。 IQVIA拥有多元化的加强型隐私技术和保障手段,能够在保护个人隐私的同时对信息进行管理和分析,帮助医疗利益相关方有效开展精准疗法,获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方,获得对疾病、人类行为和科技进步更深入的理解,共同朝着治愈各类疾病的方向迈进。
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