Osivax is a clinical-stage biotechnology company that uses its oligoDOM™ technology platform to develop innovative vaccines. Osivax's main project is a universal influenza vaccine that aims to revolutionize the prevention of seasonal influenza, currently in Phase 2a. Osivax is using this same technology to develop a broad-spectrum vaccine against SARS-COV-2, its variants or a new coronavirus pandemic.
For more information, please visit their website : www.osivax.com
Osivax has offices in France (Headquarters in Lyon) and Belgium (Affiliate in Liège). It is a growing company with over 40 employees. Their offices in Liège host about 10 employees including Clinical Operations and a Quality Control laboratory.
As part of the development of their clinical trials in Europe and worldwide, and to strengthen their clinical team in Liège, we are looking for a : Clinical Trial Assistant (M/F).
Responsibilities
Reporting to the Clinical Operations Manager, your role is to provide administrative and technical support, including regulatory activities linked to EU and US to the Clinical Operations Team and assists them with the in-house organization and the management of Clinical Trial activities. You will achieving successful delivery of the Company’s clinical activities by meeting company and regulatory requirements according to time, quality/scope and budget constraints, in coordination with other stakeholders in the clinical and other departments, vendors or subcontractors.
Your main responsibilities are:
Trial Management:
- Maintains tracking information and reference tools for clinical trial activities.
- Assists with coordination of meetings and travel arrangements.
- Attends team meetings and prepares accurate meeting minutes and log of action items.
- Provides support for trial budget follow-up.
- Maintains oversight of the purchase order process for clinical trial supplies and services, from set-up to reconciliation, as well as the processing of study invoices.
- Coordinates the ordering, packaging, shipping and tracking of clinical trial supplies and materials.
- Contributes to the overall quality of the clinical trials and key deliverables to be met
- Administrative office support.
Trial Documentation:
- Responsible for Trial Master File (TMF) management from creation to archiving, under the Clinical Project Manager’s accountability.
- Supports Clinical Operations Team by handling other Trial documentation (Essential Documents, training records and other relevant documentation).
- Supports the Clinical Project Manager (CPM) with translation of Clinical Study documents.
- Participates in the preparation of audits / inspections.
- Makes recommendations for process improvement and efficiencies.
Regulatory Affairs:
- Performs final editing and formatting of regulatory documents (Protocol, Investigators’ Brochure, DSUR, Clinical Study Report, etc.).
- Supports CPM with the Competent Authority and Ethics Committee submissions of clinical studies and related amendments.
- Maintains tracking information and reference tools with support of Regulatory for clinical trial activities linked to EC and Competent Authorities requirement.
Quality Assurance:
- Contributes to continuous improvement of Clinical Operations Quality System and Regulatory: Maintenance and development of Standard Operating Procedures and other quality documents (standard forms, etc.).
Profile
- Short or long cycle of education in life-science or healthcare related is desired.
- At least 2 years of relevant experience in clinical trial secretary in Pharma, Biotech or CRO.
- Basic knowledge related to ICH/GCP Guidelines and applicable local regulation.
- Experience on the different stages of Clinical Trials (set-up, follow-up & closure) is an asset.
- Experience as regulatory assistant is an asset.
- You have good communication and organization skills, with a very high accuracy.
- You are flexible, hands-on, proactive, eager to learn and have a good sense of responsibility.
- Fluent in English (boteh written and spoken). Speaking French or Dutch is an asset.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).
Offer
- A permanent contract and an attractive salary package in line with the position responsibilities and your experience.
- The opportunity to make a real difference in a vaccine development biotech company.
- Joining an international fast-growing team, supportive and collaborative.
- Individualized support and increasing autonomy.
- Flexible working hours, with an open, relaxed atmosphere.
Your application and related information will remain strictly confidential.