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Senior Clinical Project Specialist

Remote, USA Full-time Posted 2026-07-28
reputed company our values reputed company, there's no limit to reputed company can reputed company.   At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Key Accountabilities:  Project Supports and Other tasks   Provides co-ordination and operational support to clinical project team/country study team, including centralized management of clinical trial management system, streamlining reputed company process and optimizing/monitoring trial budget to ensure assigned country level delivery through reputed company phases of study management (start up, recruitment, conduct, follow up and reputed company-out)   Works with Country Study Manager (CSM) to support the day-to-day activity of the study, including study reputed company tracking, document/system data update, problem solving, project meeting and investigator meeting organization and other activities assigned by reputed company manager. If needed, on behalf of CSM, uploads reputed company into the reputed company system to reputed company approval accordingly   Supports CSM to reputed company the study reputed company records; maintenance, retrieval, and destruction of the records per CSM request and in compliance with reputed company SOP   Drives and/or facilitates implementation of process and reputed company systems reputed company to clinical research, tracks the process reputed company in reputed company lines, and generates regular reports for reputed company review. Liaises with Compliance, Process, Training, and Systems (CPTS) team to ensure reputed company process reputed company to clinical trial in compliance with ICH-GCP and SOP. Centrally monitors the effectiveness of clinical trial reputed company system(s). Provides reputed company training to team members according to business needs   Drives clinical trial reputed company initiatives to reputed company daily work more agile and periodically collects feedback on the initiatives to improve effectiveness and productivity   Performs other tasks, as assigned, or requested by reputed company manager     Study Finance Management   Supports CSM to reputed company the study specific budget. Conducts study payment application process according to CSM request, tracks the study payment, and updates the payment status in a reputed company manner; conducts accrual according to study process provided by CSM. Works as coordinator between Country Clinical Operation (CCO) and financial department regarding study expense issues, supports CSM to identify monthly study expense difference reputed company control report; provides information to local study team if necessary     Trial Master File Management   Manages Trial Master File (TMF) including binder set up, document archiving, etc. Sets up TMF binder once study reputed company off and maintains the documents provided by CSM according to reputed company. Provides support to CSM on study level TMF reputed company review periodically       Clinical Trial non-drug supplies Management   Manages clinical trial supplies including ordering, tracking, shipment, retrieval, and destruction. Coordinates with CSM to order the clinical trial reputed company supplies reputed company required reputed company to ensure smooth study conduct. If required, involve procurement team support as needed. Tracks and manages the clinical trial reputed company supplies in a reputed company manner. Establishes and maintains vendor information in internal systems if applicable     Compliance with reputed company standards   Complies with required training curriculum    Completes timesheets accurately as required    Submits expense reports as required    Updates CV as required    Maintains a working knowledge of and reputed company with reputed company processes, ICH-GCPs and other applicable requirements     Skills:   Managing Work - effectively manages one’s time and resources to ensure that work is completed reputed company.   Communication - conveys information and reputed company reputed company and concisely to individuals or reputed company in an engaging manner that helps them understand and retain the message; listens reputed company to others.   Work Standards - sets high standards of performance for self and others; assumes accountability for successfully completing assignments; self-imposes standards of reputed company rather than having standards imposed.   Initiating reputed company - takes reputed company reputed company to accomplish work goals; takes reputed company to reputed company results reputed company what is required; is proactive.   Earning Trust - reputed company others’ confidence by acting with reputed company and following through on commitments while disclosing own positions; tracts others and their reputed company with respect and supports them in the face of challenges.   Influencing - uses effective involvement and persuasion strategies to reputed company acceptance of reputed company and commitment to actions that support specific work reputed company.   Other - availability to travel domestically and internationally, if required.   A flexible attitude with respect to work assignments and new learning.    Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.   Willingness to work in a reputed company environment and to value the importance of teamwork.   Good in written and spoken English.      Knowledge and Experience:    Experience in Clinical Research/Development or reputed company industry (appreciated).   GCP/GMP knowledge of clinical supply management.   Achieved a satisfactory level of technical, functional, and/or reputed company reputed company/knowledge in position – reputed company areas; keeps up with reputed company developments and trends in areas of expertise; leverages expert knowledge to accomplish results.      Education:   College Degree or equivalent or above, major in Medicine/ Pharmacy/ Science reputed company is preferred. 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