Clinical Trial Operations Specialist

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 trial (s), and 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 (e.g. Clinical Trial Manger) and interface functions (i.e. Clinical Trial Supplies Unit, Sourcing, Legal) 

· Ensures cooperation with external functions (i.e. Clinical Research Organizations, advisors, investigators) 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 and support the planning of clinical trial supplies 

· 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 to ensure timely submission/re-submission 

· 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, in accordance with internal and external regulations and guidance and in adherence to the clinical trial document management process 

· Oversight of the preparation, compilation and maintenance of trial level documents (e.g. Investigator Site File (ISF) documents) in liaison with Clinical Trial Leader, Site Management Lead and other functions, relevant for submission; timely transfer of these documents to CTMs of participating countries, clarification of questions 

· Perform quality checks of trial level documents and ensure their correct formatting 

· Initiation / coordination of workflows in Documentation Management System (i.e. for the authoring of the Clinical Trial Protocol) 

· Responsible for tracking communication with Regional Operating Unit (R/OPUs) 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 

· 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, addressing the corrections and updates needed from R/OPUs 

· Ensure ICH-GCP conform distribution, retrieval, check, translation, and archival of essential documents for the Trial Master File (TMF) during the trial in close cooperation with the TMF Records Specialist and other trial team members as needed 

Clinical Trial Systems

· Ensure the appropriate set-up and maintenance of internal and external systems and tools in close cooperation with the trial team 

· Oversight of complex 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 impact 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 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; contribute to adequate control and coordination of all trial activities and processes 

· Support the trial team by compiling data for internal and external 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 groups 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 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

Skills:

· Strong communication skills; articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action

· Demonstrates active listening skills and cultural awareness and ability to have a positive impact on others to gain their support

· Demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources

· Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking

· 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. Dimensions of trial complexity include protocol, patients, sites, countries, and vendors.

· Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations. Demonstrates leadership behaviors including supporting, connecting, and enabling teams, demonstrating innovative thinking to support trial implementation. Executes activities with a clear aim to deliver 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 Elements 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 clarity to accomplish business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects.

· Cross geographical experience: Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics.

· Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous, and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions. 

· Digital Savviness: ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn and apply in a digital environment.

Education:

· Requires a university degree and/or comparable professional education with at least 5 years clinical trials experience

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