STUDY MANAGER CLINICAL PHARMACOLOGY

Major Responsibilities：

• Identifies, implements, leads and manages a Cross-functional Study Team for the duration of the study
• Responsible for development and tracking of the Study Protocol, Amendments, Informed Consent and all related documents.
• Manages, tracks, and is responsible for Submissions of study documents e.g. Study Protocol and Amendments, Study Report to the responsible ethics committees and regulatory authorities in timely manner.
• Initiate, manages, tracks and is responsible as CPharm for Clinical supply and its distribution to the study site in close collaboration with the clinical supply manager.
• Manages, tracks, and responsible for ensuring ongoing study activities, study execution and timelines are met.
• Responsible for site selection and site initiation and appropriate study related supervision of the Monitors including training for monitors and site personnel according to GCP and Bayer Global Medical Standards.
• Responsible for developing the total external study budget in close collaboration with the global function.

Requirement：

• BS degree or equivalent education with minimum 6-8 years of Healthcare experience (preferably pharmaceutical industry experience). Medical experience preferable. Position requires at least 4-5 years of clinical operations experience (e.g. monitoring, study management). Of the clinical operations experience, at least 2 years of study managment experience is preferred.
• The incumbent requires a profound knowledge of the clinical trial management process including, monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes, and budget and financial tracking.  Knowledge of study management processes is required.  Effective written and verbal communication, good knowledge of oral and written English, excellent interpersonal, motivational, team leadership, decision-making and issue resolution skills are required.  In addition, the incumbent requires proven project management skills, including effective planning and organization skills, attention to detail and excellent follow through.
• The incumbent is responsible for managing Phase I and extended Phase I/IIa less complex clinical trials.  This requires an in-depth knowledge of Good Clinical Practices (GCP), national and international regulations (International Harmonization Committee-ICH regulations).  The position also requires awareness and understanding of cultural differences as well as regional operational differences.