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 wellknown 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 and maintaining the coordination of the logistical aspects of the clinical trials in accordance with Good Clinical Practices (GCPs) and relevant SOPs. The CTA will also ensure compliance of Trial Master File (TMF) components for related clinical trials.
Main responsibilities :
- Proactive participation in the study teams and all administrative aspects of the set up and conduct of clinical trials ;
- Lead the practical and administrative arrangements and contributes to the preparation of internal and external meetings (eg Investigators Meetings) and writes meeting minutes ;
- Assists with the documentation, including TMF, EDC systems, CTMS ;
- Coordinates closely with the study team and CRO for the development of appropriate filing structure for the TMF ;
- Files documents to TMF according to TMF plan ;
- Ensures documents are filed with a high level of proficiency, according to GCP Regulations and Standard Operating Procedures and according to clinical study timeline requirements ;
- Reports TMF related metrics to clinical study teams and management ;
- Supports audit activities of TMF ;
- Trains the staff on new or revised TMF procedures ;
- Provides oversight/support and ensures compliance with the TMF inspection readiness activities ;
- Coordinates closely with the Clinical Study team and internal and external contacts for successful clinical study start-up ;
- Creates and delivers investigative site correspondence at the request of the Clinical Project Leader including clinical study newsletters, general correspondence etc.
- 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 (required)
- Significant experience with Trial Master Files (TMFs) and other clinical trial management document (required)
- Working knowledge of ICH-GCP guidelines (required)
- Experience in ophthalmology sector and/or medical device (nice to have)
- Experience in early phase trials (Phase I-II) and First-In-Man trials (nice to have)
- Read, write and speak fluent English ; excellent verbal and written communication skills
- Ability to work within a team
- Ability to be productive and successful in an intense work environment is critical
- Excellent organization and management skills
- Good negotiation and communication skills
- Results oriented
- Proactive and willing to work in a start-up environment
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company
- Full time
Please send your CV and cover letter in English to firstname.lastname@example.org