About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities - Take responsibility of all Boehringer Ingelheim China Post Marketing Studies, including Phase IV trials, IISs, RWS and other clinical programs, for the assigned TA and related products, aligned with Boehringer Ingelheim China MA strategies and according to commercial team and other medical affairs management needs. - Develop plan, lead and implement all assigned Post Marketing Studies (PMS), including Phase IV trials, IISs, RWS and other Clinical programs within/without BI China product(s) in their respective TAs. - Execute, coordinate and supervise all tasks generated by PMS trial(s), including IIS - Develop and maintain strong working relationship with investigators and their departments and/or institutes involved in approving and managing such research - Ensure that all Boehringer Ingelheim Post Marketing Studies, including Phase IV, IISs, RWS and other Clinical programs, are carried out within the planned timelines, and according to the local regulatory guidelines, ICH/GCP, and other required quality standards - Oversee performance of field trial staff (e.g. Post Marketing Study Manager 1 or Clinical Trial Assistant) and institutional study staff including monitoring, ensuring compliance with study protocol and in accordance with the scope of work and corporate timeline - Build and lead trial project team(s) in a seamless and efficient manner - Manage the selection and management of Contract Research Organizations (CROs) and/or other third-party vendors
Job Requirements - Bachelo's degree / preferably in a biologic/scientific discipline - Required for Associate Manager of PMS: - Minimum 4 years’ experience in a clinical operations including 1 year clinical project management experience in the Pharmaceutical industry and/or CRO - knowledge of clinical regulatory processes and operations as well. - Willingness and capability to handle multiple projects and responsibilities; - Very Good medical/scientific competence, interpersonal communication skills, and presentation skills - Successful, positive communications and interactions with investigators and government regulatory agencies - Well-developed networking ability - Strong analytical skills and insights - Proficiency in Microsoft Office (e.g. Word, Excel, PowerPoint, Outlook) - Able to travel nationally, regionally and internationally - Additional Required for Manager of PMS: - Minimum 6 years’ experience in a clinical operations including 3 years’ clinical project management experience in the Pharmaceutical industry and/or CRO - Very good to excellent knowledge of clinical operations and regulatory processes - Through understanding of country level regulations, ICH and GCP guidelines for trial management - Excellent understanding of cross-functional clinical process including data management, biostatistics, data analysis, data interpretation, medical writing and regulatory affairs - Proven track record of strong strategic leadership, team work, project management and mentoring talents - Experience in leading cross-functional team to meet project goals and metrics - Is results-oriented and demonstrates strong business and financial acumen
