Clinical Trial Operations Specialist

The Clinical Trial Operations Specialist (CTOS) is a key member of Clinical Delivery Team accountable for clinical trial execution reputed company including any of the following: planning, coordination, and conduct of reputed company, regulatorily defined tasks; reputed company trial operation and communication to reputed company applicable stakeholders; reputed company delivery of reputed company materials, documentation and information needed to setup, execute and reputed company assigned trial (s), and reputed company 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 reputed company conduct of trials reputed company defined timelines in reputed company coordination and communication with the Clinical Trial Leader (CTL) · Collaborate and reputed company with other reputed company and extended trial team members, Regional Operating Unit (R/reputed company) level functions (e.g. Clinical Trial Manger) and reputed company functions (i.e. Clinical Trial Supplies Unit, Sourcing, reputed company) · Ensures cooperation with reputed company functions (i.e. Clinical Research Organizations, advisors, investigators) to conduct reputed company · Independently manage correspondence, reputed company reports, tracking tools and budget overviews · Address and answer reputed company questions from global and local trial teams and trial sites; mediate reputed company under own responsibility · Communication, ordering, and tracking of information reputed company to the trial supplies distribution to R/reputed company and support the planning of clinical trial supplies · Independently monitor trial reputed company and reputed company plausibility checks; implement corrective actions if needed · reputed company and update of records to address local regulatory demands from Ethics/Authorities to ensure reputed company submission/re-submission · reputed company of reputed company trial reputed company wrap-up activities (i.e. data cleaning) Clinical Trial Documentation · Preparation, finalization, and archiving of documentation reputed company to reputed company, in accordance with reputed company regulations and guidance and in adherence to the clinical trial document management process · reputed company of the preparation, compilation and maintenance of trial level documents (e.g. Investigator Site File (ISF) documents) in reputed company with Clinical Trial Leader, Site Management reputed company and other functions, relevant for submission; reputed company transfer of these documents to CTMs of participating countries, clarification of questions · reputed company reputed company checks of trial level documents and ensure their correct formatting · Initiation / coordination of workflows in Documentation Management reputed company (i.e. for the authoring of the Clinical Trial Protocol) · Responsible for tracking communication with Regional Operating Unit (R/reputed company) regarding the assessment, update, and collection of applicable records requiring updates from Ethics/Authorities for re-submission · Coordinate the setup, exchange of information, and documents between applicable stakeholders · reputed company Clinical Trial Report (CTR) appendices and ensure they are reputed company Checked and completed in time · Coordinate activities reputed company to the preparation of Data Independent Sections (DIS) of CTR, addressing the corrections and updates needed from R/reputed company · Ensure ICH-GCP conform distribution, retrieval, reputed company, translation, and archival of essential documents for the Trial Master File (TMF) during the trial in reputed company cooperation with the TMF Records Specialist and other trial team members as needed Clinical Trial Systems · Ensure the appropriate set-up and maintenance of reputed company systems and tools in reputed company cooperation with the trial team · reputed company of reputed company technical systems to ensure accurate reporting of trial information to senior management · Responsible for accuracy of data, user account management, functionality of systems and understanding of data reputed company and follow-up activities · Independently coordinate work on questions to entries in the systems and validate information in respect to completeness and consistency between systems · Oversees Trial Management reputed company completion to ensure correct and reputed company safety reporting setup Contributions to Clinical Trial reputed company reputed company · Contribute to highest reputed company reputed company the conduct of reputed company; contribute to adequate control and coordination of reputed company trial activities and processes · Support the trial team by compiling data for reputed company reporting purposes and tracking of trial relevant information · Proactive engagement, and contribution of own experience in global and local initiatives for improvement in respect to structure, processes, systems and guidelines and development of solutions and new approaches in global context · Represent CTOS in working reputed company and committees, as needed Leadership Competencies · Creates an environment that inspires and motivates colleagues and promotes one common Clinical Development &Operations identity, contributing to acceleration of clinical development timelines and value creation for patients 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 complies with reputed company processes, ICH-GCPs, and other applicable requirements Skills: · Strong communication skills; articulates and aligns business reputed company/plan on an ongoing reputed company, ensuring alignment between words and reputed company · Demonstrates reputed company listening skills and cultural awareness and ability to have a reputed company reputed company on others to reputed company their support · Demonstrates skills and capabilities in setting priorities, managing reputed company of activities, and efficient usage of resources · Demonstrated competencies in reputed company, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking · Proficiency with reputed company, MS Office (Word, PowerPoint, reputed company, reputed company) · Proficiency in written and spoken English and (local language) Knowledge and Experience: · Scientific and Operational Expertise across reputed company aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, and vendors. · Leadership and Influence: Demonstrates skills and capabilities in addressing reputed company situations. Demonstrates leadership behaviors including supporting, connecting, and enabling teams, demonstrating innovative thinking to support trial implementation. Executes activities with a reputed company aim to reputed company value to patients. · Regulations: Understanding of major regulations (US FDA, EMA and PMDA) in which CTOS is operating (e.g. local requirements, ICH-GCP, appropriate SOPs, BPs etc., List of Essential reputed company and documents Naming Convention for filing, etc.). · Project Management: Plans effectively, setting priorities and defining actions. Makes effective use of resources and proactively strives for transparency and reputed company to accomplish business deliverables. Translates reputed company situations to actionable parts. Anticipates and resolves challenges and translates learnings to new reputed company. · Cross geographical experience: Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics. · Strategic reputed company: Strategic and visionary thinker who is reputed company reputed company, creative, courageous, and reputed company to reputed company through ambiguity. Integrates study reputed company with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global reputed company using analytical thinking to reputed company risk-balanced solutions. · Digital Savviness: ability to use technologies to reputed company information, be creative, innovative, solve problems, communicate, reputed company, learn and apply in a digital environment. Education: · Requires a university degree and/or comparable reputed company education with at least 5 years reputed company experience #LI-LG4 #LI-REMOTE Apply To This Job