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

• Responsible for study and regional/country level activities from study startup through conduct and study close • Partners with various study management roles to ensure coordinated approach to studies • Provides leadership and strategic planning to ensure operational delivery of study tasks • May close out studies post database lock • Accountable for execution of tasks and developing solutions to study-related problems • Responsible for implementation of Startup and Site Activation Plans • Manages communication with internal stakeholders and vendors • Ensures timely completion of Quality Events and audit readiness during startup and conduct • Supports implementation of new tools and technologies for studies

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 • BS/BSc/MS/MSc • 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