Job Description

Country Study Specialist

Belgium Pharmaceuticals Employee
Posted by Sonia Vandekerkhove on 07/07/2020

For our sponsor, a big pharma company in the Brussels area, we are looking for a Country Study Specialist. This position requires CRA experience. Please read the job description below and make yourself known if you recognize yourself in it! 

Job purpose:

The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs). The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.

Tasks:

  • Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring that company’s quality and safety standards, regulations, timelines, and budget commitments are met
  • Provides input into and/or develops study related materials
  • Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required
  • Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non­productive sites and tracking of safety procedures
  • Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection
  • Executes all start-up activities prior to site activation on assigned studies, aligned with study/project requirements and timelines
  • Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country
  • Partners with CSMs and CSSs to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations
  • Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs)
  • In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required

Qualifications & Requirements:

  • University Degree or equivalent, preferably in a medical/science-related field
  • Fluent in English/ Dutch or English/ French
  • Demonstrated knowledge and understanding of clinical trials
  • Experience in managing projects
  • Demonstrated knowledge and understanding of ICH-GCP, as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials
  • Monitoring experience is desirable
  • Previous experience as CRA/ CRA lead is a big asset
  • Previous line management experience/ supervision is an asset
  • Reside in Belgium

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