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Clinical Project Lead – Ophthalmic micro-invasive Medical Device - Wavre

Company

The Company

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.

Role

What you will be doing

The “Clinical Project Lead” reports to the “Vice President 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

Other Clinical activities as directed by the VP Head of Regulatory and Clinical Affairs

Profile

Required experiences and qualifications

  • You have at least 5 years of experience in managing clinical trials in Medical Device industry (preferably Class II or Class III 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 up to 30% of time
  • and last but not least, you are eager to learn and stress resistant

Offer

The offer

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.

Publication date

15.09.2019

Contact person

Sophie Gravy

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