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 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 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. • Helps guide the Study Management strategy by providing accurate updates on tasks delegated to them. • Ensures operational delivery of responsible tasks within assigned studies, in accordance with appropriate quality standards. • Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. • Manages study startup process in assigned countries and/or oversees pCRO responsible for these activities. • Supports the Country/investigator outreach process, site identification, and feasibility. • Ensures compliance to relevant Global and Local requirements and regulations. • Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan. • Manages applicable Quality Events with local team as applicable and required.

Requirements

• Relevant operational clinical trial experience • A scientific or technical degree is preferred along with knowledge of clinical trial methodology • BA/BS 5+ years of relevant experience • MBA/MS 3+ 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. Prior Experience • 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