Clinical Project Manager
il y a 2 semaines
OSIVAX is a 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.
Osivax has offices in France (Headquarters in Lyon) and Belgium (Affiliate in Liège). It is a growing company with over 40 employees. Our offices in Liège host about 10 employees including Clinical Operations and a Quality Control laboratory.
As part of the development of our clinical trials in Europe and worldwide, we are looking for a:
**Clinical Project Manager (F/M)**
**Office-based in Liège, BELGIUM**
**Permanent position**
**Full time**
**YOUR TASKS & RESPONSABILITIES**:
Reporting to the Clinical Operations Manager / Director of Clinical Development, you will join the Clinical Operations team based in Liège, as a Clinical Project Manager.
You will manage all the aspects of the trial(s) under your responsibility, whether operational, technical or logístical, in accordance with Good Clinical Practice and the regulations in force.
First point of contact, your missions will be:
- Manage clinical studies in an autonomous way from initiation to completion
- Selection of partners including CROs and investigational sites
- Contribute to the development and/or review of study documents including the protocol, informed consent form, clinical study report and several operational plans
- Facilitate and coordinate communication between all stakeholders involved (internal and external) and lead project steering meetings
- Supervise CRO activities including regulatory submissions, monitoring, data management, biostatistics, logistics for IMPs, study materials, biological samples and immunological analyses
- Plan and track schedule, budget, and deliverables
- Identify, evaluate the risks and ensure the implementation of action plans and their follow-up
- Follow the CAPA audits until finalization
- Contribute to the improvement of the quality system
- Supervise the Trial Master File
**YOUR BACKGROUND & PROFILE**:
You have a minimum of a Master’s degree in natural sciences, health engineering, medicine or pharmacy. You have a first successful experience of 5 years in a similar position in the pharmaceutical or medical device industry (pharmaceutical or biotechnology company, CRO).
You have a good knowledge of the management of clinical studies, from start to completion.
Previous CRA and/or project management experience in the field of vaccinology would be an asset.
Fluent in English, you enjoy working in an international and multicultural environment. Speaking French or Dutch is an asset.
Solution-oriented, flexible, organized and proactive, you are pragmatic and rigorous. Your analytical, writing and interpersonal skills will enable you to succeed in this very cross-functional position.
In a growing company, you will be able to actively participate in the evolution of the activities.
- Advanced level of Microsoft tools (Word, Excel, PowerPoint, Teams)
**TERMS OF EMPLOYMENT**:
- Remote work up to 2 days a week
- Possibility of working part-time (80 or 90%)
**Salary**: From €60,000.00 per year
Schedule:
- Day shift
Supplemental Pay:
- Yearly bonus
**Education**:
- Master's (required)
**Experience**:
- clinical trial: 5 years (required)
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