Global Study Leadership

3 semanas atrás

Buenos Aires Espírito Santo Brazil IQVIA Tempo inteiro
Overview

Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to ensure delivery requirements are always met.

Responsibilities
  • Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
  • Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place.
  • Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project lifecycle.
  • Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, and monitoring and overseeing management of clinical quality issues.
  • Identify clinical stakeholder landscape for the project and manage internal and external stakeholders through effective communication and resolution management.
What you need to have
  • Bachelor's Degree in health care or other scientific discipline required.
  • Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Requires broad protocol knowledge and therapeutic knowledge.
  • Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
  • Communication - Strong written and verbal communication skills including good command of English language.
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