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 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 contribute to global and local initiatives for improvement in 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.