Sr Project Specialist (Sponsor Dedicated/Remote)

Job Responsibilities

• Plan, coordinate, and conduct trial activities according to ICH-GCP.
• Affirm the seamless execution of trials within defined timelines in close collaboration and communication with the Clinical Trial Leader (CTL).
• Collaborate and interact with trial team members, Local Clinical Trial Managers (CTM), and interface functions (e.g., Clinical Trial Supplies Unit, Sourcing, others).
• Cooperate 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.
• Support the planning of clinical trial supplies.
• Keep an overview of records and update them to address local regulatory demands from Ethics/Authorities to ensure timely submission and re-submission.
• Collaborate in internal/external audits.
• Organize and supervise all trial-related wrap-up activities (e.g., data cleaning).
• Ensure the appropriate setup and maintenance of internal and external systems and tools.
• Support the trial team by compiling data for internal and external reporting purposes and tracking of trial-relevant information.
• Proactively engage and initiate contributions 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.

Qualifications

Experience as a Project Specialist at the CRO and Sponsor level clinical trial oversight and responsibilities is preferred in the FSP organization as this role is a dedicated representative of the sponsor team in clinical trials.