Core Job Responsibilities:

1. Clinical Study Projects:

• Conducts Clinical Study Projects from study start-up to final study report, including (Co-) monitoring, managing and/or coordinating in- and external resources per project basis and aligning activities to agreed timelines and deliverables.
• Ensure the pharmacovigilance compliance to both company and local regulations for responsible clinical study projects in alignment with CROs.
• Oversees and manages CROs and other second vendor activities (such as Study management, risk management, monitoring) and supports study budget controlling and tracks budget relevant milestones.
• Organizes and coordinates outsourcing for activities related to clinical trial conduct like monitoring, Project Management, Medical Writing, Registration and follows-up on deliverables.
• Acquire, maintain and share knowledge / expertise related to CTM and to project specific medical / scientific aspects; To provide insights from the sites of potential needs of protocol amendment to resolve problems to ensure on track deliverables.
• Contributes to and/or advises on update of processes, guidelines and procedures relevant for Clinical Trial Management
• Serve as a key contact for issue resolution and liaison between global team and China Affiliate.
• Support to enable the quality management system including but not limit to vendor evaluation, internal QC, audit and inspection.

2. Clinical Development Program

• Responsible for providing clinical development expertise to business development team and project teams on clinical development programs for potential product candidate for China.
• Supporting branded generics plans or ITBs to expand or maintain EPD compounds on the market in China.
• Act as the Regional Project Manager in a regional project or product team on assigned projects.
• Interacts with the Project Teams operating in this TA including Commercial, Regulatory Affairs, and other disciplines to ensure that the clinical project fulfills the regulatory requirements and represents the company to the Regulatory bodies as appropriate on clinical matters.
• Performs other duties as assigned or requested.