Clinical Site Management Specialist

5 giorni fa


Roma, Lazio, Italia Syneos Health Clinical A tempo pieno

About Us

We are Syneos Health Clinical, a leading biopharmaceutical solutions organization dedicated to accelerating customer success. Our team is passionate about developing innovative solutions to meet the evolving needs of our customers and patients.

At Syneos Health Clinical, we understand the importance of site selection and contract management in the clinical trial process. That's why we're seeking a skilled Regulatory Contract Coordinator to join our team. In this role, you will provide critical support to site selection lead and Project Manager (PM)/SSU Leadership (SSUL), ensuring that the right sites are selected for individual studies based on the requirements of the clinical trial.

You will also assist in the administration of contract management and essential document processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents. Your attention to detail and organizational skills will be crucial in ensuring that contracts are reviewed and compliant with SOPs and Work Instructions (WIs).

Key Responsibilities

  • Site Selection Support
  • Contract Management
  • Quality Control and Translation Processes
  • Negotiations of Budget and Contracts
  • Review and Compliance of Contracts
  • Active Project Management
  • Communication Liaison
  • Functional Guidance and Team Awareness
  • Correspondence and Document Preparation
  • Contract Execution and Archival
  • Compliance and Timesheet Management

Requirements

  • Associate's Degree or equivalent combination of education and training preferred.
  • Good understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Ability to interact effectively and appropriately with investigative site personnel and internal stakeholders.
  • Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
  • Ability to take direction from multiple individuals and set priorities accordingly.
  • Ability to effectively communicate across multiple function groups (Clinical team, PM, Director).
  • Demonstrated ability to work


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