Position: Global Trial Manager Location: Hyderabad, (Hybrid - 5 days in 2 weeks) Key Skill: Clinical trial, Clinical study(end to end), Project Management, Budgeting and Vendor Management. Qualifications & Experience BA/BS or equivalent degree in relevant discipline. Minimum 8 years of demonstrated project management experience of which at least 4 should have been in the pharmaceutical or healthcare industry. Experience in leading global clinical trials and multi-functional teams. Demonstrated project management and organizational skills with strong presentation and communication abilities. Experience with electronic quality, compliance and CTMS systems. Experience in managing CROs is a plus. Risk management experience preferred. Position Summary Act as the primary operational contact for the study and leads the cross-functional global team for execution of the study. Key Responsibilities: Directs and delegates to assigned Global Trial Management staff as applicable. Drives study execution utilizing available performance metrics and quality indicators (e.g. CTMS, eTMF reports, RBM reports), and study milestones and drivers. Develops, manages, and maintains study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions. Technical Competencies: Clinical trial project management skills. Financial budgeting and forecasting skills are a plus. In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes. Proven success in using oral/written communication skills to influence, inform, or guide others. Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint Proficiency in study tools including electronic system skills - e.g. CTMS/eTMF. Demonstrated project management and organizational skills with strong presentation and communication abilities. Ability to manage multiple deliverables and nimbly respond to changing business demands. Management Competencies: Understands interdependencies, links possible solutions, and escalates issues with proposed solutions to appropriate people. Critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines. Has the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of BMS (as appropriate). Has the ability to review, interpret, and analyze information to support discussions and make decisions. Ability to effectively lead a cross-functional team in a matrix environment. Time management skills - ability to effectively multi-task and set priorities with minimal guidance.
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