Pfizer
To apply science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe • effective and affordable medicines and health care services to the people who need them.
10,000+
💰 Post-IPO Debt on 2023-05
Study Operations Manager
5 days ago
Pfizer
To apply science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe • effective and affordable medicines and health care services to the people who need them.
10,000+
💰 Post-IPO Debt on 2023-05
Description
• The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. • The cSOM partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out. • The cSOM has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. • The cSOM ensures the operational delivery of responsible tasks within the assigned studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. • Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. • Work independently and exercise their own judgement. • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. • Provides protocol level guidance and support to responsible Local Study Team members as applicable. • Ensures timely communication bidirectionally between the global and local study team. • Ensures compliance to relevant Global and Local, internal and external requirements and regulations.
Requirements
• BSc/MSc degree is required. • A scientific or technical degree is preferred along with knowledge of clinical trial methodology. • 5+ years of relevant experience. • Relevant operational clinical trial experience. • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility. • Demonstrated clinical research experience and/or study management/startup project manager experience. • Demonstrated experience in managing country level operational activities and/or vendors. • Experience in Study and Quality management and working in a matrix management environment. • Expertise in the use of study/site dashboard and reporting tools. • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization. • Detail oriented & possesses technical expertise. • Ability to manage moderately complex processes. • Risk Identification & Mitigation. • Strategic Planning, Analytical and Problem-Solving Skills. • Critical Path Analysis. • Ability to adapt to changing technologies and processes. • English is required.
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