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