PlusOne

Clinical Project Leader - CRO - muskuloskeletal and rheumatological

Company & Responsibilities

Our Customer is a niche CRO focused on activities related to muskuloskeletal and rheumatological disorders.

If you are looking for a company on a human scale where everyone has their place and every opinion counts this position is for you.

With a reputation for transparency, flexibility and highly focused on being able to deliver with excellence, this customer is looking for a Clinical Project Leader available immediately. The CPL will be part of the Clinical Unit and will be the person responsible for clinical trials on food supplements, medical devices and drugs.

Main Tasks

  • Trial design based on Sponsor’s requests
  • Protocol writing
  • Training and supervision of CRAs and Flying Nurses
  • Supervision of site identification and feasibility
  • Submission and correspondence with Ethic Committees and Competent Authorities
  • Together with CRAs
    - Preparation of clinical documentation and TMFs
    - Management of queries, issues and deviations
    - Management of clinical materials and products
    - Ensuring safety management
  • Supervision of SIV, MOV and COV activities
  • Involvement in eCRF design and database set up with the Data Manager
  • Close communication with Sponsor, CRAs, Data Managers, statisticians and any other third party
  • Reporting to the Sponsor
  • Involvement in trial budget
  • Ensuring timeline, budget and quality are met
  • Contributing to the development of investigator and expert scientist network

Profile

  • University degree in Life Sciences, PhD preferred
  • Past experience as CPL in private company or public institution
  • Past experience as CRA is an asset
  • GCP training
  • Excellent knowledge of clinical trial guidelines and regulatory environment
  • Fluent in French/English (written and spoken), Dutch is an asset
  • Driving license with own car


Soft skills

  • Willingness to integrate a small structure where versatility and flexibility are key factors
  • Responsible attitude, rigor, tact and courtesy
  • Ability for quick adaptation and autonomy
  • Leadership
  • Excellent communication, organizational and planning skills
  • Excellent analytical skills to identify and understand problems and to propose and follow-up taken action
  • Team spirit

Location

Liège

Publication date

30.06.2020

Contact person

DORTU

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