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Clinical Trial Associate

Clinical Trial Associate Clinical Trial Associate Clinical Trial Associate
19/01/2023 Innovation
  1. 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 headquarters. This collaborative environment allows a positive synergy between R&D activities, production, logistics and administration. Our technological platform is in the Science Park of Liège.

To support its development, EyeD Pharma is hiring a Clinical Trial Associate.

Your responsibilities

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.

  • 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
  • Assist with the documentation, including TMF, EDC systems, CTMS
  • 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.
  • 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
  • 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
  • Coordinate closely with the Clinical Study team and internal and external contacts for successful clinical study start-up
  • Create and negotiate investigative site budgets and contracts according to limits established by the Clinical Project Leader
  • Create and deliver investigative site correspondence at the request of the Clinical Project Leader including clinical study newsletters, general correspondence etc.

Your profile :

  • Master degree in Life Sciences, Nursing Licensure or Pharmacy or equivalent by experience (preferred)
  • A minimum of 3 years of experience in a biotechnology/pharmaceutical industry or other related relevant experience (required)
  • Significant experience with Trial Master Files (TMFs) and other clinical trial management document (required)
  • Working knowledge of ICH-GCP guidelines (required)
  • Therapeutic experience in ophthalmology and/or medical device (preferred)
  • Experience in early phase trials (Phase I-II) and First-In-Man trials (preferred)
  • 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 ;
  • Liège (Sart-Tilman)


Please send your CV and cover letter in English to : job@eyedpharma.com

 

Our values

Patient Driven

All our product candidates aim to enhance patient quality of life and are based on clinical unmet need identified by internationally renowned KOL’s

Patient Driven
Breakthrough Innovation

We manage all the expertise and processes, from the idea to the market

Breakthrough Innovation
Corporate Responsibility

Creation of high-quality long-term employment and significant contribution to the economic redeployment of Wallonia. Eyed’s team is today composed of 66 FTEs

Corporate Responsibility
Humanitarian Mission

Our technological platform allows to give access to long term innovative ophthalmological treatments to developing countries populations, where glaucoma is the second cause of blindness

Humanitarian Mission