Country Start-up Specialist

Highly Competitive
  1. Permanent
  2. Clinical Scientist
  3. Belgium
Brussels
Posting date: 12 Jun 2019
CR.TS.23817_1560333591

A leading global contract research organisation is seeking to recruit a Country Start-up Specialist to their office in Brussels. The company provides comprehensive, integrated drug development, laboratory, and lifecycle management services, working with partners across pharmaceutical, biotechnology, medical device, academic, and government organizations. This is an exciting opportunity to work with a company that has offices in 48 countries and more than 20,000 professionals worldwide, with a commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

Job Responsibilities:

  • Preparing, reviewing, and coordinating local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, and import licenses) in alignment with global submission strategy.
  • Providing local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Providing project specific local SIA services and coordination of these projects.
  • Contacting investigators for submission related activities.
  • Acting as the key contact at country level for either Ethical or Regulatory submission-related activities.
  • Coordinating with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines;
  • Ensuring the alignment of submission process for sites and study are aligned to the critical path for site activation.
  • Achieving company target cycle times for site.
  • Working with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
  • Developing country specific Patient Information Sheet/Informed Consent form documents.
  • Assisting with grant budgets(s) and payment schedules negotiations with sites.
  • Supporting the coordination of feasibility activities, as required, in accordance with agreed timelines.
  • Entering and maintaining trial status information relating to SIA activities onto company tracking databases in an accurate and timely manner.
  • Ensuring the local country study files and filing processes are prepared, set up, and maintained as per company WPDs or applicable client SOPs.
  • Maintaining knowledge of company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Skills and Requirements:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, and experience.
  • Good English, Dutch, and French language and grammar skills.
  • Basic medical/therapeutic area and medical terminology knowledge.
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Theodora Savlovschi - Wicks at +44 203 752 0314 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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