Role Description The Clinical Trial Operations Specialist (CTOS) is a key member of the Clinical Delivery Team accountable for clinical trial execution excellence including any of the following: - Planning, coordination, and conduct of complex, regulatorily defined tasks - Seamless trial operation and communication to all applicable stakeholders - Timely delivery of all materials, documentation, and information needed to setup, execute, and deliver assigned trials - Oversight of trial supplies, submissions, and other operational parameters Key Accountabilities - Clinical Trial Operations - Accountable for the planning, coordination, and conduct of trial activities according to ICH-GCP - Assures the seamless conduct of trials within defined timelines in close coordination and communication with the Clinical Trial Leader (CTL) - Collaborate and interact with other core and extended trial team members, Regional Operating Unit (R/OPUs) level functions, and interface functions - Ensures cooperation with external functions to conduct clinical trials - Independently manage correspondence, complex reports, tracking tools, and budget overviews - Address and answer complex questions from global and local trial teams and trial sites; mediate decisions under own responsibility - Communication, ordering, and tracking of information related to the trial supplies distribution to R/OPUs - Independently monitor trial progress and perform plausibility checks; implement corrective actions if needed - Overview and update of records to address local regulatory demands from Ethics/Authorities - Oversight of all trial related wrap-up activities (i.e. data cleaning) - Clinical Trial Documentation - Preparation, finalization, and archiving of documentation related to clinical trials - Oversight of the preparation, compilation, and maintenance of trial level documents in liaison with Clinical Trial Leader and other functions - Perform quality checks of trial level documents and ensure their correct formatting - Initiation / coordination of workflows in Documentation Management System - Responsible for tracking communication with R/OPUs regarding updates from Ethics/Authorities - Coordinate the setup, exchange of information, and documents between applicable stakeholders - Generate Clinical Trial Report (CTR) appendices and ensure they are Quality Checked and completed in time - Coordinate activities related to the preparation of Data Independent Sections (DIS) of CTR - Ensure ICH-GCP conform distribution, retrieval, check, translation, and archival of essential documents for the Trial Master File (TMF) - Clinical Trial Systems - Ensure the appropriate set-up and maintenance of internal and external systems and tools - Oversight of complex technical systems to ensure accurate reporting of trial information to senior management - Responsible for accuracy of data, user account management, and functionality of systems - Independently coordinate work on questions to entries in the systems - Oversees Trial Management System completion to ensure correct and timely safety reporting setup - Contributions to Clinical Trial Quality Oversight - Contribute to highest quality within the conduct of clinical trials - Support the trial team by compiling data for internal and external reporting purposes - Proactive engagement in global and local initiatives for improvement - Represent CTOS in working groups and committees, as needed - Leadership Competencies - Creates an environment that inspires and motivates colleagues - Compliance with Parexel 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 complies with Parexel processes, ICH-GCPs, and other applicable requirements Qualifications - Strong communication skills; articulates and aligns business strategy/plan - Demonstrates active listening skills and cultural awareness - Demonstrated competencies in Agility, Accountability, and Intrapreneurship - Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) - Proficiency in written and spoken English and local language Knowledge and Experience - Scientific and Operational Expertise across all aspects of clinical trial planning and execution - Leadership and Influence: Demonstrates skills in addressing complex situations - Understanding of major regulations (US FDA, EMA, PMDA) - Plans effectively, setting priorities and defining actions - Working in a multi-cultural environment; strong understanding of corporate culture - Strategic and visionary thinker who is future focused - Ability to use technologies to access information and solve problems Education - Requires a university degree and/or comparable professional education with at least 5 years clinical trials experience EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.