Study Operations Manager

4 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 Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. • The cSOM partners with various stakeholders to ensure a coordinated approach to study startup, execution and close out. • Provides leadership and strategic planning to ensure operational delivery of tasks within studies. • Accountable for executing tasks and developing solutions to support deliverables. • Responsible for country vendor management and oversight including follow up and coordination of vendor deliverables. • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution.

Requirements

• Extensive operational clinical trial experience • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology • BA/BS 7+ years of relevant experience • MBA/MS/ 6+ years of relevant 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 • 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 • 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

Benefits

• Paid parental leave • Access to Health & Wellness apps • Career Growth Experiences program • Recognition & rewards program • Paid volunteer days • Life Insurance Benefits • Pfizer Learning Academy access to top content providers • Access to flu vaccines & skin checks • Options to purchase additional leave