Pfizer Study Manager in Beijing, China
Role Summary : The Senior Study Manager acts as the single point of contact for all responsible studies. The Senior Study Manager has accountability for the study end to end delivery throughout study design, start-up, conduct, analysis& reporting, study close-out, inspection readiness, submission and regulatory defense for one or more single/multiple countries studies.
The Senior Study Manager is accountable for developing the operational strategy and managing the timelines, budgets, and quality across more complex studies, such as Asian studies, Global studies and studies that do not follow a currently defined model within DC.
The Senior Study Manager is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category (ies).
And Senior Study Manager lead and manage the core cross functional stakeholder for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.
The Senior Study Manager is responsible for the line management of junior study manager, Clinical Research Associate (CRAs) to ensure quality, oversight and efficient execution of Pfizer clinical trials within the country/region in accordance with Pfizer standards, applicable laws and business needs.
The Senior Study Manager is responsible for monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc.) and take appropriate targeted action. Conducts risk assessments to identify actions for mitigation and control across studies. And conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.
Qualifications (Training, Education & Pr ior Experience):
Minimum of BS/BA in a biomedical discipline or equivalent education/training is required
At least 7 years in clinical practices
Good working knowledge of Good Clinical Practices (GCPs), monitoring, clinical drug development process and country regulatory environment
Experience with clinical research methodology (e.g., study design, study monitoring and data
analysis). Prior study management and/or study coordination experience preferred.
Demonstrated effectiveness in working in a multidisciplinary, matrix team situation.
Effective verbal and written communication skills in relating to colleagues and associates both inside
and outside the organization.
- Advanced education and/or training/experience desirable.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.