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Study Coördinator/Clinical Project manager (junior level)

Summary

For a company in Brussels at the Brussels Midi station we are looking for a Study Coordinator/ Clinical project manager.

Job Description

The Study Coördinator / Clinical PM will administer, maintain and co-ordinate various logistical aspects of clinical trials in accordance with standards procedures and guidelines and acts as a pivotal point of contact for the study team. You will support the Study or Study Team and complete tasks assigned to enable the Team to meet study timelines and deliverables for all steps of the clinical trial process.

Responsibilities

  • Organize study set-up activities.
  • Ensure that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory and contractual requirement.
  • Write or contribute to preparation of study protocol, informed consent forms and any other clinical research related documents.
  • Assist principal investigators with Ethics Committees and/or Competent Authorities submissions and filing necessary supportive documentation.
  • Track site contracts approvals, invoices and payments (sites, vendors,…).
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH GCP regulations and study specific manuals and procedures
  • Review key study quality metrics (e.g. eligibility, primary endpoint data, safety data,…) and propose/implement strategies to solve potential issues in conjunction with the study team
  • Report risks/issues that can affect the study and work to the study team to implement corrective actions
  • Ensure appropriate filing of study documents in the trial master file.
  • Oversee the timely production of the final Clinical Study Report (CSR) in collaboration with the statistical team and study chair
  • Organise study close down activities
  • Support the department development of documentation and process improvement
  • Lead and/or organize (dates, agenda, creation and collation of meeting materials, joining instructions, attendance records, minutes, etc.) meetings and training sessions
  • Perform any other duties as assigned

Requirements

  • Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
  • Experience in the set-up and management of all operational aspects of clinical trials (in academia, industry, or CRO).
  • Knowledge of methodologies, regulations and procedures related to clinical trials.
  • Possess strong analytical skills and highly organized project management abilities, keeping an eye on both detail, while maintaining a broad overview.
  • Native or native-like written and spoken Dutch and English, knowledge of French is a plus.
  • A high level of integrity and sense of responsibility.