Associate Director, Country Clinical Trial Management

Associate Director, Country Clinical Trial Management Shanghai, China | full time | Job ID: 11391

Your main responsibilities are:

• Lead and Drive study delivery in China
• Support in preparation of regular status reports to local DCO and global CTM/Platform Lead, including presentation of project status in meetings
• Overlooking the clinical operation trial budget in country level
• Opportune contact with PM and ADCO in case of divergences from the project plan
• Oversight on project timelines and deliverables in country level
• Set-up or oversight of study related documents such as Trial Management Plan, Monitor Manual, etc.
• Contribution to and review of study core documents and contribute to local customization, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
• Coordination of project activities with other internal departments or external vendors from start-up to close out of a clinical trial
• Support in planning and conduct of project training prior to starting project activities, oversight
• Responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with leading the operational project team, the supervision/ control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved
• Support on clinical operational function development in China with the guidance of DCO, including but not limited to support on GCO initiative delivery in China
• China KOL engagement ability with the support from clinical dev and GMA
• Engage with and provide oversight to our CRO partners in China
• CRO and other vendor (including but not limited to SMO, referral company, QC/QA vendor, etc.) collaboration and oversight to ensure the high quality and full compliance
• Ensure the quality and integrity of outsourced clinical trials
• Actively identify and manage any internal and external risks to the business
• Build and maintain strong relationships with local vendors including but not limited to CROs, patient advocacy groups and SMOs at strategic and operational levels
• Build processes and act