Sr Project Specialist (Sponsor Dedicated/Remote)

Job Responsibilities

• Responsible for planning, coordination and conduct of trial activities according to ICH-GCP.
• Affirms the seamless conduct of trials within the defined timelines in close coordination and communication with the Clinical Trial Leader (CTL).
• Collaborates and interacts with trial team members, Local Clinical Trial Managers (CTM), and interface functions (e.g., Clinical Trial Supplies Unit, Sourcing, others).
• 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 trialsites.
• Support the planning of clinical trial supplies.
• Keep overview of records and update of records to address local regulatory demands from Ethics/Authorities to ensure timely submission and re-submission.
• Collaborate in internal/external audits.
• Organization and supervision of all trial related wrap-up activities (e.g., data cleaning).
• Ensure the appropriate set-up 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.
• Proactive engagement and 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 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.