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Clinical Trial Site Relationship Manager

hace 2 meses

Xico, México Novartis A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Trial Site Relationship Manager to join our team at Novartis. As a key member of our Global Drug Development team, you will be responsible for ensuring the successful start-up of clinical trials at sites in Mexico.

Key Responsibilities
  • Manage site relationships and ensure timely start-up activities from country allocation to site greenlight
  • Conduct site selection visits and verify site eligibility for specific studies
  • Main contact for trial sites during site selection, study start-up, and IRB/IEC and HA submission preparation
  • Ensure milestones and time schedules for study start-up are met as planned
  • Facilitate preparation and collection of site and country level documents
  • Collect submission relevant site-specific documents within agreed timelines
  • Support SSU Manager in preparation of country-specific documents
  • Negotiate investigator payments as needed
  • Support preparation of financial contracts between Novartis and investigational sites and investigators
  • Update all systems until site Green Light on an ongoing basis
  • Support preparation of audits and inspections as applicable
  • Support reduction of formal site-specific IRB/IEC deficiencies
  • Ensure timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
  • Ensure adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
  • Implement innovative and efficient processes in line with Novartis strategy
Requirements
  • Minimum 3 years' experience in clinical operations in a monitoring/site management role
  • Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
  • Central/in-house monitoring or field monitoring experience is desirable
  • Strong site management capabilities with demonstrated negotiating and problem-solving skills
  • Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
  • Strong interpersonal, negotiation, and conflict resolution skills
  • Ability to travel for site selections, if applicable
  • Ability to manage multiple priorities and manage time efficiently
  • Fast change adaptability to best partner & influencing with sites on fast changing landscape
  • Trust and rapport building is a very important skill needed
  • Good communication skills, ability to influence others & Relationship management
Education

A degree in scientific or health discipline, preferably with clinical operations experience (or, for United States: 4-year degree plus relevant, related healthcare experience)

Language

Fluent in both written and spoken English, local language as needed