上海招聘

Tasks & responsibilities:
? Responsible for the preparation and approval of country related submission packages within specific timelines and quality standards.
? Responsible for the collection of site level critical documents for Investigational Product (IP) release and site activation
? Responsible for the review and approval of site level critical documents for Investigational Product release and site activation
? Responsible for the negotiation of site level contracts to ensure sites are activated within the agreed timelines
? Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned
? Provide country specific regulatory and submission expertise to project teams, across multiple countries
? Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies
? Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
? Prepare, finalize and review Master and Country Specific EU Clinical Trial Application Forms and corresponding data files (xml file)
? Review and translate Drug Labels and advise Sponsor on knowledge content for development of Drug Labels

Experience & competences:
? Minimum of 1 year of experience in the clinical research environment, preferably with Study Start Up experience
? Key competences as
? Collectively working to the end goal: the ability to focus on the objectives and to formulate decisions, attitudes and collaborative skills to realise the outcome.
? Proactively: See an opportunity, to seize the initiative, or to prevent or correct a process – “many energised hands makes light work”
? Dynamic mental agility: within SSUS many priorities exist, the ability to work to the importance and not the urgency is critical
? Win-win: naturally strive for the mutually beneficial solution, to generate and maintain strong working relationships, via trust and loyalty

A global leading company focus on the drug research, clinical research and providing Clinincal operation solution for world famous pharamcy company. We have over 9000 people all of the World and entered into China in 2005. Will with a good development plan to broaden and improve China business scale.