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
Senior 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 Senior Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. • The cSOM partners with various role to ensure a coordinated approach to study start up, execution, and close out. • The cSOM provides leadership and strategic planning and organization skills to ensure the operational delivery of tasks. • The cSOM may be responsible for closing out one or more studies post database lock.
Requirements
• BSc/MSc degree is required. • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. • 7+ years of relevant experience. • Extensive operational clinical trial experience. • Demonstrated clinical research experience and/or study management/startup project manager experience. • Demonstrated knowledge of site selection, site activation, site readiness interdependencies. • Demonstrated knowledge of clinical trial methodology and the drug development process. • Demonstrated experience participating on cross functional teams. • Demonstrated experience in Project Management and Quality Management. • Demonstrated experience in a matrix management environment. • Expertise in the use of study/site dashboard and reporting tools. • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility. • 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 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.
Benefits
• Equal Employment Opportunity • Disability Inclusion • Flexible Workplace Culture
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