TMF Document Specialist(I/II/Sr)社

面议

市辖区

发布时间：2023-09-06

职位描述

JOB SUMMARY
Performs support tasks related to the set-up, maintenance and close out of the Trial Master File. Serve as Subject Matter Expert to coach junior team members.

JOB RESPONSIBIITIES
Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.Support the set-up, maintenance, and closure of TMF repositories.Support documentation collection activities, including:Document scanning and indexing for trial using an electronic TMFDocument filing for trials using a paper TMFPerform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified Maintain compliance with departmental quality, performance and utilization targets Complete administrative tasks (e.g., status reports) as requestedMaintain compliance with company requirements (e.g., time tracking, training)Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipmentsParticipates in study specific training as requiredFor Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control RoomEnsures the security and compliance of all documents related to active and archived projectsAbility to support complex/study specific systems/processesSupports logistics for the flexible workforce, as applicableAbility to work independently with minimal supervisionAttend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate; lead facility tours if office-based where audits are conductedProvide oversight, training and support to more junior members of document management upon management requestAssist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance


Other Responsibilities:

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).


QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)


Undergraduate degree and/or related experience with courses in the scientific/regulatory field or equivalent related work experience. Experience in a clinical and/or medical environment required. Familiarity with electronic TMF system required. Strong knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology. Demonstrable leadership skills. Strong verbal, written, and organizational skills with a team-oriented approach. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Proficiency in Microsoft Office Suite and Adobe Acrob**************************

其他要求

招聘人数：1人
职能类别：其他运营推广职位

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