Post Approval Study Manager

작업 내용

A Global Top10 Pharmaceutical Company is looking for a Clinical expertise in Taiwan, Taipei to identify, approach and maintain high-quality strategic scientific partnerships with medical experts and other relevant external partners.Key Responsibilities

• Lead operations of post-approval studies - Non-Interventional Study (NIS) and Investigator-Initiated Research (IIR), across therapeutic areas, ensuring medical governance and compliance of these studies, as well as delivery of quality data
• Support new drug applications by coordinating country assessment report (regulatory requirement for registration study)
• Accountable for all site management activities and procedures for NIS to ensure quality, compliance, efficiency and effectiveness of the sites for these trials
• Manages the internal Site Management budget, including oversight of external clinical grants annually. External clinical grants include all costs associated with applicable NIS and IIRs clinical trials (investigator payments and study supplies)
• Ensures efficient and adequate resources for each clinical trial
• Liaise closely with medical advisors and MSLs of relevant TAs to ensure success of studies
• Contract handling, vendor management, budget management and administrative coordination of patient support programs in consultation with program responsible Medical Advisor
• People management responsibility, ensuring competency training and professional development of all post-approval study team members
• Efficient execution of NIS & IIR to ensure quality delivery and in compliance with internal requirements and local legal and regulatory requirements
• Develop clinical investigator network in the country to support efficient clinical trial execution and contribute to business strategy