Clinical Trial Operations Specialist
Location
Canada
Posted
2 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Trial Operations Specialist
Parexel
Role Description The Clinical Trial Operations Specialist (CTOS) is a key member of 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 - 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 Regional Operating Unit (R/OPUs) - 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 - Responsible for accuracy of data, user account management, 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, and contribution of own experience in global and local initiatives - Represent CTOS in working groups and committees, as needed - Leadership Competencies - Creates an environment that inspires and motivates colleagues 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 Requirements - Scientific and Operational Expertise across all aspects of clinical trial planning and execution - Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations - Understanding of major regulations (US FDA, EMA and PMDA) - Plans effectively, setting priorities and defining actions - Working in 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
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