Study Operations Manager

December 13

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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+ employees

Founded 1849

💰 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 the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out. • The cSOM has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. • The cSOM may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks. • The cSOM ensures the operational delivery of responsible tasks within the assigned studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. • Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. • The cSOM will be accountable and responsible for tasks as designated on the study by the Global Study Manager.

Requirements

• Relevant operational Clinical Trial experience. • A scientific or technical degree is preferred along with knowledge of clinical trial methodology. • MBA/MS 3+ years of relevant experience BA/BS 5+ years of relevant 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 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. • Detail oriented & possesses technical expertise. • Ability to manage moderately complex processes. • Ability to operate 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.