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12 jul 2019

Part-Time Clinical Project Lead – Ophtalmic micro-invasive Medical Device

StepStone – Gepost door ZELBA Waals-Brabant

Job Omschrijving

Our Client is a clinical stage, VC backed medical technology company headquartered in Wavre, Belgium. Based on its innovative, proprietary material, our Client has developed a pipeline of next-generation micro-invasive glaucoma systems (MIGS), addressing issues encountered with currently marketed MIGS devices. Glaucoma is the second leading cause of adult blindness globally. MIGS represent the most promising and fastest-growing therapeutic option in the treatment of glaucoma.
 


The “Clinical Project Lead” reports to the “Vice President Head of Regulatory and Clinical Affairs” and covers the following tasks:

  1. Take lead of all clinical activities including management of any CROs
  2. Develop and/or review specific study-related documents
  • Clinical Investigation Plan (CIP/Protocol),
  • Patient Information (PI), Informed Consent (IC), English version
  • Investigator Brochure (IB),
  • Synopsis
  1. Coordinate preparation of study-related documents
    • Prepare and review CRFs
  2. Support process of Trial Site Selection
    • Build a strong relationship to investigators and team members on site
    • collect and review relevant due diligence information of site
  3. Support / Coordinate submission to Competent Authorities (CA) and Ethical Committee (EC)
    • Develop and/or review documents for CA
    • Develop and/or review documents EC
  4. Trial Set-up Activities
    • Site related coordination for clinical study
    • Develop and/or review (if CRO) Trial Operations Manual (MOP)
  5. Investigator/Team Meeting
  • Attendance and presentation at investigator meeting/s
  • Attendance and presentation at CRA training meeting/s
  • Support investigators with publications
  • Establish and improve relationship with KOLs and clinical trial investigators
  • Write “newsletters” with updated information on a regular basis for sites participating in ongoing or planned trials, report final summary
  1. Project Management & Administration
  • Proposal to close down Trial sites
  1. Study Monitoring
    • Coordinate all monitoring CROs and check status of studies regularly
    • Support during treatment of first patient on site
    • Perform co-monitoring visits
    • Review clean CRFs
    • Ensure CA and EC informed about GCP breach
    • Review of annual safety reports to CA and EC
  2. Data Management
    • Coordinate all CROs and check status of studies regularly
  3. Other Clinical activities as directed by the VP Head of Regulatory and Clinical Affairs


Required experiences and qualifications

  • You have at least 5 years of experience in managing clinical trials in Medical Device industry (preferably Class II B implants) as well as experience in pharmaceutical clinical affairs
  • You have acquired strong Project Management skills. You are able to lead your own studies autonomously and to handle complexity related to multiple sites/countries/stakeholders
  • You are capable to coordinate many stakeholders across different countries
  • You have experience in discussing directly with Investigators and other Stakeholders 
  • You hold a Master degree in Life Sciences, Biomedical Engineering, Chemistry…
  • A good knowledge of GCP (Good Clinical Practices) is desired
  • A knowledge in ophthalmology will be considered as a plus
  • You are completely fluent in English both written and spoken – the knowledge of other European languages is a strong plus

 

Soft skills

  • You are a true “field person” driven by contacts and interactions
  • You are a committed Team player demonstrating positive and constructive attitude to solve problems
  • You have very good leadership capabilities
  • You give attention to details
  • You have good organizational skills and you manage your time and planning effectively
  • You are open to travel in Europe from 25% up to 50% of time
  • and last but not least, you are eager to learn and stress resistant


Our Client offers a full-time permanent position or a long-term free-lance contract along with an attractive remuneration package.

The position is based in Belgium (Wavre) and has a european scope (area to be defined).

You will be part of a highly skilled (engineers, scientists) and dynamic team headed by a solid management team. The team is very stable, a large part of the staff is present since the beginning in 2011.

This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.


Job Categorieën : Andere: R&D, wetenschap en wetenschappelijk onderzoek, Biotechnologie, Optiek & akoestiek, Project Management en Research en development Job Types: Part-Time

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