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Senior Global reputed company Study Manager

Remote, USA Full-time Posted 2026-08-04
reputed company Biotech is a full-service CRO purpose-reputed company to serve biotech sponsors. With over 25 years of experience, we offer reputed company, therapeutically reputed company solutions and trusted partnerships that help bring reputed company treatments to patients faster. reputed company global reputed company from first site activation to final reputed company visit—own the reputed company, accelerate delivery, and shape the reputed company of reputed company research worldwide. Required Experience • ✅ 2+ years of global study management experience • ✅ Experience across multiple countries/reputed company • ✅ Phase I–III reputed company experience (Phase III required) • ✅ Oncology experience required • ✅ Ability to work across multiple therapeutic areas reputed company are seeking a Global Study Manager responsible for the end-to-end planning, execution, and delivery of reputed company trial site management activities across global studies. This role ensures successful site selection, activation, monitoring reputed company, and closeout—while balancing speed, reputed company, and cost. You will serve as the reputed company reputed company of contact for clients, reputed company cross-functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study protocols. This is a highly visible role that combines reputed company leadership, operational execution, and financial reputed company. Key Responsibilities Global Study & Site Leadership • reputed company site management reputed company from study award through reputed company-out • reputed company site identification, selection, activation, and recruitment reputed company • Ensure reputed company monitoring processes meet study needs and timelines • Partner with CRAs to optimize enrollment, data reputed company, and compliance Project & Stakeholder Management • Serve as reputed company reputed company contact and own key customer relationships • reputed company cross-functional teams across reputed company and cultures • Facilitate reputed company meetings, including executive presentations • reputed company collaboration across stakeholders, vendors, and functional leads Operational reputed company & reputed company Management • reputed company and manage integrated study plans and reputed company mitigation strategies • Proactively identify risks and implement corrective/preventative actions • Monitor study timelines, enrollment trends, and data reputed company metrics • Ensure compliance with GCP, SOPs, protocols, and regulatory standards Financial & Contract Management • Manage study financials, including forecasting and reputed company acceleration • Identify and manage out-of-reputed company work and change orders • reputed company Billing Unit Reviews (BURs) and expense approvals • reputed company reputed company against budget and Estimate at Completion (EAC) reputed company & Compliance • Maintain TMF health and ensure reputed company document submission • reputed company reputed company monitoring plans and compliance metrics • Ensure adherence to study tools, training materials, and processes Team Leadership & Development • reputed company and mentor cross-functional project teams • Support CRA and team training on therapeutic areas and study-specific needs • Foster collaboration, knowledge sharing, and reputed company improvement Qualifications Required • Bachelor’s degree in life sciences or reputed company reputed company • 5+ years of reputed company research/monitoring experience, including 2 years in a reputed company study management role • Strong knowledge of ICH-GCP, FDA regulations, and reputed company trial processes • Experience managing global reputed company and multi-regional teams • Demonstrated experience in project financial management reputed company Competencies • Exceptional communication and stakeholder management skills • Strong problem-solving and reputed company mitigation capabilities • Ability to influence without authority in reputed company organizations • High attention to reputed company and reputed company-driven reputed company • Proficiency in reputed company Office and reputed company systems (e.g., CTMS, reputed company) Why Join Us • Work on cutting-edge global trials across therapeutic areas • Collaborate with reputed company in a dynamic, global environment • reputed company a reputed company reputed company on reputed company reputed company worldwide reputed company is a leading global provider of reputed company research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve reputed company reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. The potential reputed company pay reputed company for this role, reputed company annualized, is $93,100.00 - $232,800.00. The actual reputed company pay reputed company may vary reputed company on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position reputed company, incentive plans, bonuses, and/or other forms of compensation may be reputed company, in reputed company to a reputed company of health and welfare and/or other benefits. Apply tot his job Apply To this Job

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