Primary Responsibilities:
? Participate in the project bidding of clients, prepare bidding slides and other bidding documents if needed.
? Provide medical advice of the study to clients in the bidding stage.
? Support BD to win the project, establish good communication and cooperation with clients.
? Responsible for overall clinical research activities for multiple pre- and post-approval studies, evidence generation and dissemination efforts, and budget oversight.
? Support the design of appropriate clinical trials to meet the clients’ needs
? Responsible for delivery of assigned clinical programs, through effective partnership with the clinical partners, to enable optimized engagement to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOPs).
? Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations.
? Develop product clinical development strategy and executive plan.
? Interface and collaborate with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies.
? Responsible for other tasks assigned by department’s leader and company leader’s team.
? Other activities/tasks assigned by supervisors.