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无工作经验 -
招若干人 -
01-08 发布
职位描述
Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards; responsible for independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards; develop and finalize Master and Country Specific Information Sheets / Informed Consent Forms (SIS/ICFs).Accountable for the collation and verification of the submission documentation in assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate in assigned countries. Produce and deliver local regulatory, submission and sponsor specific training for assigned country level personnel. Coordinate reporting activities to sponsor and clinical teams. Attend study specific meetings as required. Participate in business development activities and client meetings, as assigned.Mentor / train new and junior personnel in SSU. Lead and/or serve as consultant on Investigator Contract and Budget development process from origination through finalization. Review and negotiate Investigator contracts and budgets.Maintain communication with Investigative sites, Sponsors and internal personnel regarding status of contract and contract-related documents. 职能类别： 医药技术研发管理人员
联系方式
南京西路288号创兴金融中心
公司信息
ICON Clinical Research-- a top global CRO company. For more details, please kindly see our website - http://www.iconplc.com/
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