Clinical Trial Site Partner

hace 1 semana


Xico, México Pfizer, S.A. De C.V A tiempo completo

Company Overview: Pfizer, S.A. De C.V is a global leader in the pharmaceutical industry, dedicated to making breakthroughs that change patients' lives.

Estimated Salary: $120,000 - $180,000 per annum

About the Role: We are seeking an experienced Clinical Trial Site Partner to join our team. As a key member of our site management team, you will be responsible for building and retaining investigator site relationships, providing support from site recommendation through the lifecycle of studies, and ensuring site-level recruitment and operational success.

Responsibilities:

  1. Deploy GSSO site strategies by qualifying and activating assigned sites
  2. Support processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection
  3. Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision
  4. Maintain a thorough knowledge of assigned protocols
  5. Conduct study start-up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation
  6. Ensure all the site initiation activity including training per site activation checklist, collect and complete necessary documentation/systems needed for site activation (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
  7. Support country specific ICD review and deployment when applicable
  8. Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
  9. Partner with site monitor to ensure site monitoring readiness in anticipation of first subject first visit
  10. Responsible for relationship building and operational oversight of the site
  11. Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts and payment issues etc.)
  12. Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
  13. Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators
  14. Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals e.g. recruitment, data entry timelines etc.
  15. Partner with local RA/CTRO/SAP to ensure timely completion on country/local registry when applicable

Requirements:

  • A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
  • At least 5 years demonstrated experience in site management with prior experience as a site monitor
  • Demonstrated experience in start-up activities through to site activation
  • Demonstrated experience in conduct and close-out activities
  • Demonstrated knowledge of quality and regulatory requirements in applicable countries
  • Skills in more than one language are an advantage in this role
  • English is required
  • Ability to manage required travel of up to 75% on a regular basis

Benefits: Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Work Location Assignment: Hybrid



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