Clinical Trial Assistant
Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities.
In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.
To support its development, EyeD Pharma is hiring a Clinical Trial Assistant
The Clinical Trial Assistant (CTA) is responsible for establishing, maintaining and ensuring compliance of Trial Master File (TMF) components for related clinical trials.
- Proactive participation in the study teams and all administrative aspects of the set up and conduct of clinical trials
- Assist with the documentation, including TMF
- Ensure documents are filed with a high level of proficiency, according to GCP Regulations and Standard Operating Procedures and according to clinical study timeline requirements
- Coordinate closely with the study team and CRO for the development of appropriate filing structure for the TMF
- File documents to TMF according to TMF plan.
- Report TMF related metrics to clinical study teams and management
- Support audit activities of TMF
- Train the staff on new or revised TMF procedures
- Provide oversight/support and ensures compliance with the TMF inspection readiness activities
- Lead the practical and administrative arrangements and contributes to the preparation of internal and external meetings (eg Investigators Meetings) and writes meeting minutes
- Coordinate closely with the Clinical Study team and internal and external contacts for successful clinical study start-up
- Support logistical activities related to clinical trials
- Bachelor degree in Life Sciences or equivalent by experience
- A minimum of 1 year experience in a similar function of Clinical Trial Assistant in a biotechnology/pharmaceutical industry and in management of Trial Master Files (TMFs)
- Working knowledge of ICH-GCP guidelines (required)
- Read, write English;
- Ability to work within a team
- Ability to be productive and successful in an intense work environment is critical
- Excellent organization and time & administrative management skills.
- Good communication skills
- Proactive and willing to work in a start-up environment.
- A permanent position in an innovative, dynamic and fast growing company;
- Full time ;
Mots clés : medical device, ophthalmology, development, pharmaceutical, ocular pathologies, research scientist, quality, drug product, lead, life sciences, sciences appliquées, innovation, technical documentation, dispositifs médicaux, ISO14971, ISO13485, Risk management, assurance qualité, clinique, clinical, GCP, secteur pharmaceutique, data manager, CRO, TMF, CRA
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