上海招聘

RESPONSIBILITIES

l Responsible for performing quality control (QC) review in accordance with standard operating procedures (SOPs), work instructions (WIs), ICH GCP guidelines, TMF reference model and study specific TMF Plans.

a) Ensure TMF documents meet good documentation requirements (GDP) by confirming RUTOLA (Retrievable, Unique, Translations, Original, Legible, Applicable) principles

b) Ensure documents that fail TMF QC review are effectively remediated by internal/external document owners

c) Monitor the progress in resolution of identified TMF discrepancies, escalate if needed

l Serve as the TMF point of contact for internal and external (CRO) team members

a) Maintain and report TMF compliance metrics for assigned studies

b) Provide education, feedback and support to study teams in order to build knowledge and awareness of GDP

l Oversee management of vendors providing TMF services

a) Establish and maintain collaborative relationships with TMF vendors

b) Oversee vendor TMF QC processes

l Assist with TMF process development

a) Perform user acceptance testing for Veeva eTMF

b) Contribute to the development of TMF SOPs, work instructions, reference guides, naming conventions and TMF user training

l Assist in the archiving of eTMF documents transferred from 3^rd party vendor

REQUIREMENTS:

Education: Bachelor’s degree required; scientific discipline preferred

Minimum of 2 years of clinical research experience required

Minimum of 2 years of relevant document management, quality content review, and comprehensive completeness review experience required

Experience in TMF required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews

Excellent organizational and communication skills

Our mission is to build a preeminent biopharmaceutical organization to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets.

Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.