Global Clinical Project Manager-MD

Job Description

• The Global Clinical Project Manager (GCPM) manages and is responsible for all operational aspects and contributes to the strategic execution of assigned Phase II-IV global development projects, within the approved Clinical Development Plan (CDP). The initial GCPM hires into the Global Development sitein Beijing must be trained and experienced as an M.D. physician.  They will be expected to contribute to the global strategyand scientific communicationsfor their respective CDP.  These projects are conducted within the standards set by the Bayer Global Development and Compliance Organization and according to Good Clinical Practices and applicable regulatory and legal requirements.  As a team member of the Global Clinical Development Team (GCDT), the Global Clinical Project Manager coordinates and provides input to the GCDT to create the agenda, track action points and ensure there is accurate tracking and management of the overall CDP. Given the parameters from the Global Clinical Project Leader (GCL), input from participating countries and study requirements, the Global Clinical Project Manager develops, controls and is responsible for the overall operational project budget and informs the GCL of budget issues and concerns. The overall objective of the Global Clinical Project Manager is to manage the planning, implementation, analysis and reporting of assigned clinical projects within the established timeframes and budget in close cooperation with the assigned study managersand the study medical experts, with the quality and requirements necessary for global regulatory approvals. The Global Clinical Project Manager is expected to be able to contribute to protocol development, study reports and regulatory documents as well as support and implement ideas and suggestions for global process improvement efforts.
• Coordinates Global Clinical Development Team that is chaired by the Global Clinical Leader
• Contributes to protocol development, study reports and regulatory documents
• Works closely with the Global Clinical Leader in developing project strategy and risk/benefit assessments
• Creates concept trials in IMPACT to obtain study numbers, facilitate functional planning, and provide bulk drug supply information to Customer Relations
• Discusses and plans bulk clinical drug supply requirements, comparators and blinding options with Customer Relations
• If needed, develops the outsourcing plan together with the head of External Supplier Management and the global functional heads.  Reviews and approves CRO contracts.  Manages CRO budgets using tools provided by ESM
• Defines the Key Performance Indicators (KPI's) for the clinical program
• Day to day planning and management of clinical timelines, clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved ressources

Requirement:

• The incumbent for the initial GCPM hires requires an M.D. degree with a number of 3-5 years of clinical experience. 
• Including medical training, theequivalent ofa minimum of 8 years of pharmaceutical industry experienceis needed.  The position requires a minimum of 5 years of pharmaceutical clinical operations experience including direct monitoring and clinical trial/study management experience  or the equivalence in academic research.  Of the 5 years, 3 years should be in pharmaceutical developmentand 2 years can be in academic research.
• The incumbent requires an in depth knowledge of the clinical trial management process, regulatory requirements, drug safety requirements, data management and statistical processes, and budget and financial tracking.  Effective written and verbal communication, good knowledge of oral and written English, strong oral presentation, excellent interpersonal, motivational, 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 should have leadership skills including the ability to lead teams and issue manage in multi-functional teams.
• The incumbent is responsible for managing Phase II-IV global clinical programs.  This requires an in-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations).  The position also requires awareness and understanding of cultural differences as well as regional operational differences.