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Local Trial Manager, Single Sponsor Dedicated, home based anywhere in Portugal

3 meses atrás


Oeiras, Lisboa, Portugal Pharmiweb Tempo inteiro

The Role

As Local Trial Manager, you will be in charge of overseeing international studies in various therapeutic areas, managing project operations to fulfill contractual obligations. As the main contact person, you will lead, manage, and organize clinical trials from start to finish at a country level, following ICH-GCP and local regulations.

RESPONSIBILITIES OVERVIEW

  • Collaborate with global and local teams, as well as the study team, to develop country strategies, ensure study progress, and oversee country-level study execution.
  • Plan, supervise, and provide oversight of clinical study implementation according to the global program strategy by leading the Local Study Team (LST).
  • Assist in country-level operational planning and take charge of site selection within assigned country(ies).
  • Contribute to the development of program/study-specific materials such as monitoring plans and training documents.
  • Set site-level goals and ensure study-specific deliverables for clinical sites in the designated country(ies).
  • Take part in or lead CRA, Investigator, and Study Coordinator training.
  • Supervise vendor activities like laboratories and equipment provisioning.
  • Contribute to the investigational product forecast at the study level, support accountability and reconciliation, and manage the ELE process.
  • Monitor the progress of the clinical study in terms of timelines, deliverables, and budget for the assigned country.
  • Review country and study trends, as well as Monitoring Visit Reports.
  • Identify and help resolve study-specific issues across functions.
  • Provide updates on the study budget and seek approval for budget deviations at clinical sites.
  • Conduct on-site quality visits with CRAs as needed and aid in maintaining investigator site relationships.

REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree in a healthcare or related scientific field.
  • Minimum 2-3 years of experience leading local/regional or global teams.
  • Minimum 2-3 years of clinical trial project management experience.
  • Experience overseeing external vendors (e.g., CROs, central labs, imaging vendors, etc.).

REQUIRED KNOWLEDGE

  • Local expertise in regulatory environment, study startup processes, and associated timelines.
  • Understanding of clinical trial procedures and operations.
  • Proficiency in ICH/GCP regulations and guidelines.
  • Project and program management skills, including oversight of study deliverables, budgets, and timelines.
  • Familiarity with time, cost, and quality metrics, as well as Key Performance Indicators (KPIs).

Meet IQVIA

IQVIA is a prominent global provider of innovative analytics, technology solutions, and clinical research services to the life sciences sector. Our goal is to push the boundaries of human and data science to have a significant positive impact and help our clients advance global health. Explore more at