Study Operations Manager

5 days ago

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Pfizer

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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 cSOM is responsible for regional/country level activities from study startup through conduct and study close. • The cSOM partners with the Global Study Manager and others to ensure a coordinated approach to study management. • Accountable for execution of tasks and developing solutions to support deliverables. • Responsible for country vendor management and oversight. • Ensures compliance with required regulations and standards. • Responsible for management/oversight of regional activities for study startup through to close out. • Supports implementation of Pfizer's technologies and systems to enhance operational efficiency. • Responsible for data cleaning deliverables and country-level input during planning. • Ensures timely communication between global and local study teams. • May act as a Subject Matter Expert and lead operational initiatives.

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.