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Clinical Site Activation Specialist

1 mese fa

Roma, Lazio, Italia Pfizer A tempo pieno
Job Summary:

The Clinical Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

Key Responsibilities:
  • Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
  • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable.
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, for internal regulatory approval within required timelines.
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
  • Collection of documents needed from sites for EU-CTR submission. Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Support & implement activities in Shared Investigator Platform (SIP) to align with Pfizer strategy as it relates to the role.
  • Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, and other activities required during study conduct.
  • Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
  • Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections.
Internal & External Communication:
  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
  • Provide functional updates on a country and site level as required.
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
  • Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable.
  • Communicate Local sites approvals to study team members and stakeholders.
Clinical Trial Site Support:
  • As needed, perform, awareness session with site personnel on Pfizer requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.
  • Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues.
Additional Responsibilities:
  • A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country.
  • May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country.
  • May be assigned as an SME on a system and/or process, and represent the SAP function as applicable.
  • May represent the SAP role on global initiatives.
  • Able to act as an SME on projects and initiatives, as requested.
  • Support the mentoring of new hires on processes/ systems.
Systems & Tools:
  • Ability to use and learn systems, and to use independently.
  • Microsoft Suite.
  • Clinical Trial Management Systems (CTMS).
  • Electronic Trial Master File.
  • Electronic Investigator Site File (e.g. Florence).
  • Document exchange portals.
  • Shared Investigator Platform.
  • Ethics, National Networks and Governing Bodies Portals and platforms (as needed).