Senior Project Specialist – Sponsor Dedicated
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Job Description
Planning and coordinating clinical trial activities according to ICH-GCP for Syneos Health. Collaborating with trial team and managing all trial-related tasks in a timely manner.
Responsibilities:
- Responsible for planning, coordination and conduct of trial activities according to ICH-GCP.
- Assures the seamless conduct of trials within the defined timelines in close coordination and communication with the Clinical Trial Leader (CTL).
- Collaborate and interact 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 trial sites.
- 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
Requirements:
- Responsible for planning, coordination and conduct of trial activities according to ICH-GCP.
- Assures the seamless conduct of trials within the defined timelines in close coordination and communication with the Clinical Trial Leader (CTL).
- Collaborate and interact trial team members, Local Clinical Trial Managers (CTM) and interface functions (e. g. Clinical Trial Supplies Unit, Sourcing, others)
- 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 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
Benefits:
- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself.
- Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We’re a growing, global company dedicated to advancing our talent past their initial role.
- Collaborate with passionate problem solvers Partner with the most diverse team of experts in the industry.
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