Study Start-Up Specialist (M/F)

Eurotrials Ver Empresa

Não especificado
Licenciatura

Eurotrials, Scientific Consultants, is a privately owned company founded in Lisbon, Portugal, in 1995 by members of academia, medical community and pharmaceutical industry.

Recently Eurotrials was pleased to announce that they were acquired by CTI Clinical Trial & Consulting. CTI has grown consistently and significantly, becoming a multi-national organization with associates in more than 35 countries across the world. CTI has worked on more than 3,500 projects, worked on every continent and have contributed to more than 100 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others.

Staying true to its roots, CTI focusses on chronically and critically ill patient populations.

At CTI / Eurotrials we believe in the value of our employees, we encourage our employees to pursue long-term careers and we invest largely in continuous, ongoing and specialized training.

Our recruitment process values candidates with:

  • Talent and enthusiasm
  • Excellent technical capacities and professionalism
  • A drive towards outstanding ethics

In order to support our exponential growth, we are looking for a dynamic and motivated professionals to join the Start-Up team in Portugal.

Are you ready to become involved in complex clinical trials?

This is the organizations for you!

Requirements:

  • Science Degree or higher Education in Health Sciences;
  • Minimum of 6 months experience of Regulatory and Study Start Up activities and documents submission to the authorities;
  • Demonstrated understanding of the clinical research process and medical terminology, as well, as of ICH-GCP and regulatory, ethics and contractual requirements for starting and conducting clinical trials in the country;
  • Strong communication skills, with proven ability to objectively present facts and defend an action plan;
  • Excellent organizational skills and work methodology, being able to prioritize and manage multiple tasks with flexibility;
  • Experience in working as a part of a team and contributing to improve team’s performance;
  • Fluent in English, both written and spoken;
  • Computer literacy, experience with a clinical trial management system is a plus.

Activities to Develop:

  • Prepare, review and submit initial studies applications, and subsequent submissions, amendments, status reports and safety notifications, to Competent Authorities, Central Ethics Committees, Local Ethics Committees and other bodies, as applicable;
  • Review, adapt and customize Informed Consent Forms, Labels and other study material, in accordance with applicable guidelines, legislation and country-specific requirements;
  • Collect/review Essential Documents needed for Site Activation;
  • Act as a consultant providing expertise on local regulatory submission process and requirements, both to Client and/or Study Management;
  • Collaborate with Study Management providing up to date input to metrics and status reports, contributing to Start-Up cycle time improvement;
  • Review and negotiate contracts and budgets with investigational sites, ensuring appropriate terms use and customization according to local applicable legislation, duties and responsibilities of all parties involved;
  • Contact with the Clinical Monitoring Team for discussing study exams, procedures and particularities (involvement of other site Units, extra fees agreed with Sponsor, etc.);
  • Contact with investigational site staff and Administration Boards for contracts approval process progress until fully execution.

We offer:

  • Competitive Remuneration according to experience and function;
  • Integration in a young and dynamic team;
  • The opportunity to be part of a growing multi-nacional company that is involved in state of the art trials.

If you have these requirements, please send us your application.

If your application is successful, you will be contacted, otherwise your application will remain in our database for future opportunities.

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