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Site Activation Specialist

2 meses atrás

São Paulo, São Paulo, Brasil IQVIA Argentina Tempo inteiro

About the Role

The Sr. Site Activation Specialist will serve as the primary point of contact for investigative sites, ensuring seamless site activation and management for North American sites in accordance with applicable regulations, standard operating procedures, and project requirements.

Key Responsibilities

  • Under general supervision, serve as the Single Point of Contact (SPOC) for assigned studies, ensuring adherence to standard operating procedures, quality of designated deliverables, and project timelines.
  • Perform feasibility, site ID, start-up, and site activation activities according to applicable regulations, SOPs, and work instructions, distributing completed documents to sites and internal project team members.
  • Prepare site documents, reviewing for completeness and accuracy, and ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  • Review and provide feedback to management on site performance metrics, ensuring monitoring measures are in place and implementing contingency plans as needed.
  • Inform team members of completion of feasibility, site ID, regulatory, and contractual documents for individual sites, and review, track, and follow up on the progress, approval, and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, ICF, and IP release documents, in line with project timelines.
  • Provide local expertise to Site Activation Managers and project teams during initial and ongoing project timeline planning, and perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

Requirements

  • Bachelor's Degree in Life Science or related field.
  • Around 3-4 years of clinical research experience, with mandatory experience in the site activation and regulatory department, with experience working with the US and Canada being desirable.
  • Advanced level of English, as you will be working with sites in North America.