Country Study Operations Manager

October 16

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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 Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close. • The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. • Partners with the Global Study Manager, and others to ensure a coordinated approach to study start up, execution and close out. • Provides leadership and strategic planning to ensure the operational delivery of tasks within one or more studies, in accordance with quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements. • May be responsible to independently take on the closing out of one or more studies post database lock.

Requirements

• Extensive operational clinical trial experience • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology • BA/BS with expert applicable knowledge and relevant experience • MBA/MS with solid advanced and demonstrable experience • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility • English is required. • Demonstrated clinical research experience and/or study management/startup project manager experience • Demonstrated knowledge of site selection, site activation, site readiness interdependencies clinical trial methodology and the drug development process • Demonstrated experience participating on cross functional teams in Project Management and Quality Management in a matrix management environment • Expertise in the use of study/site dashboard and reporting tools • Detail oriented & possesses technical expertise • Ability to manage complex processes • Ability to manage in a matrix environment • Risk Identification & Mitigation • Strategic Planning, Analytical and Problem-Solving Skills • Critical Path Analysis • Excellent communication skills, both written and verbal • Ability to adapt to changing technologies and processes • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization