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Clinical Trial Operations Specialist

3 months ago

Burlington, Canada Boehringer Ingelheim Full time
The Position
The Clinical Trial Operations Specialist (CTOS) is a key member of the Clinical Trial Team and is accountable for clinical trial execution excellence including:
  • Planning, coordination, and conduct of complex, regulatorily defined tasks
  • Seamless trial operation and communication to all applicable stakeholders
  • Timely delivery of all the materials, documentation, and information needed to set up, execute, and deliver the assigned trial(s)
  • Independently take care of complex technical systems to manage clinical trials for correct reporting to senior management
  • Oversight of trial supplies, documentation, submissions, and other operational parameters
The CTOS works independently but in close collaboration with Clinical Trial Leader (CTL) and other trial team members, liaising closely with the Clinical Trial Managers (CTM) in all R/OPUs for all trial-related issues, including support for regional/local trial activities where applicable.
Responsibilities
Clinical Trials Operational Side
  • Accountable for 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).
  • Seamlessly collaborate and interact with other core and extended trial team members, R/OPU level functions (e.g. CTM) and interface functions (e.g. Clinical Trial Supplies Unit, Sourcing, Legal). Smooth cooperation with external functions (e.g. Clinical Research Organizations, advisors, investigators) to conduct clinical trials.
  • Independently manage correspondence, complex reports, tracking tools, and budget overviews in English language
  • 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 based on this information, support the planning of clinical trial supplies
  • Keep an overview of records and update of records to address local regulatory demands from Ethics/Authorities to ensure timely submission and re-submission.
  • Organization and supervision of all trial-related wrap-up activities (e.g. data cleaning)
  • Independently monitor trial progress and perform plausibility checks, if needed, to implement corrective actions
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 CT Leader, SML, and other functions, needed to conduct a clinical trial and relevant for submission; timely transfer of these documents to CTMs of participating countries, clarification of questions
  • Perform quality check of trial-level documents and ensure their correct formatting (e.g. Informed Consent)
  • Initiation/coordination of workflows in Documentation Management System (e.g. for the authoring of the Clinical Trial Protocol)
  • Responsible to track the communication with R/OPUs regarding the assessment, update records, and collection of applicable records requiring updates from Ethics/Authorities for re-submission.
  • Coordinate the setup, the exchange of information and documents between the applicable stakeholders (e.g. trial team, vendors etc.).
  • Generate Clinical Trial Report (CTR) appendices and ensure they are Quality Checked and complete in time
  • Coordinates activities related to the preparation of Data Independent Sections (DIS) of CTR, addressing the corrections and updates needed from R/OPUs
  • Ensure the complete and ICH-GCP conform distribution, retrieval, check, translation, and archival of essential documents for the Trial Master File (TMF) during the entire course of the trial in close cooperation with the TMF Records Specialist and other trial team members as needed.
Maintenance of Systems
  • Ensure the appropriate set-up and maintenance of internal and external systems and tools under own responsibility in close cooperation with the trial team. Responsible for accuracy of data, user account management, functionality of systems while having a deep understanding of data impact and follow-up activities
  • Independently coordinate work on questions to entries in the systems. Validate information in respect to completeness and consistency between systems
  • Oversees Trial Management System completion to ensure correct and timely safety reporting setup.
Contribution to Quality and Oversight
  • Contribute to the highest quality within the conduct of clinical trials; to 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, own initiative, and contribution of own experience in global and local initiatives for improvement in respect to structures, processes, systems, and guidelines and development of solutions and new approaches in a global context. Represent CTOS in working groups and committees, as needed
  • Supervision of smooth trial conduct via oversight systems
Leadership Competencies
  • Creates an environment that inspires and motivates colleagues and promotes one common CD&O identity, contributing to acceleration of clinical development timelines and value creation for patients.
  • Gain a full understanding of their role and responsibility and to drive execution independently. Fosters a learning culture by sharing learnings.
  • Embraces innovative/digital technologies, as well as creates and maintains a culture that drives empowerment, smart risk-taking, and one common CD&O identity
Interface Management
  • Ensure an effective and efficient interface management through professional communication and interaction in English language with the internal trial team, experts, and support groups; through resolving questions of external stakeholders and partners; to create adequate collaboration platforms
  • Delegate work packages and special requests to competent specialists and interfaces; follow-up until resolution
This position is based in the Burlington, Ontario office located at 5180 South Service Road and is flexible.
Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.
Requirements
  • University degree qualified and/or comparable professional education with at least 5 years' experience in the area of clinical trials.
  • Strong and proven track record with a background in administrative management of CTs. Long-standing working experience in international context and cross-functional project work.
  • Strong Communication Skills: Demonstrates AAI approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness. Ability to have a positive impact on others, to persuade or convince them in order to gain their support.
  • Scientific and Operational Expertise: Demonstrates operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.
  • Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations. Demonstrates leadership behaviors of supporting, connecting, and enabling teams, demonstrating innovative thinking to support trial implementation. Executes activities with a clear aim to deliver value to patients.
  • Strategic Mindset: Strategic and visionary thinker who is future-focused, creative, courageous, and able to navigate through ambiguity. Embraces cross-functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions.
  • Coordination and Oversight: Collaborative team member who demonstrates skills and capabilities in setting priorities, managing the pace of activities, and efficient usage of resources.
  • Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts. Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.
  • Digital savviness: Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
  • Regulations: Good understanding of the regulatory framework 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.)
  • Relevant language skills: Fluent in written and spoken English
  • Effective cross-functional collaborations: Ability to develop and maintain relations, alliances, and coalitions within and outside the organization and to use them in order to obtain information, support, and cooperation
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