Clinical Project Leader (CPL)

Published on 22/01/2021

Responsibilities

With a reputation for transparency, flexibility and highly focused on being able to deliver with excellence, Artialis 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 Site Initiation visit (SIV)
    - Preparation of clinical documentation and TMFs
    - Management of queries, issues and deviations
    - Management of clinical materials and products
    - Ensuring safety management
  • Coordination of SIV, MOV and COV activities
  • Close communication with Sponsor, CRAs, Data Managers (if any third party), 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
  • Data management in support of Data Manager
    - Preparation of data management documents and eCRF
    - Design of reconciliation of study databases
    - Collection, cleaning and management of subject data in compliance with regulatory standards
    - Data validation, queries and DCF
    - Database finalization, lock and extraction
    - Quality control

Profile

  • University degree in Life Sciences, PhD preferred
  • Past experience as CPL in private company or public institution with significant track records of succesfully conducted trials
  • Willingness to develop ddata management skills
  • Good knowledge of computer science
  • 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

Offer

Located in Liege (Belgium), Artialis (www.artialis.com) is a biotechnology company offering to the pharma and food industry pre-clinical and clinical trials services based on innovative imaging and biological markers.

You will integrate a dynamic clinical team within a versatile environment and a small family structure. You will be a key player in a great team, where you can grow and directly contribute to the success of clinical trials.

Application

If you are interested to apply to this position, please send a cover letter and CV both in English to: berenice.costes@artialis.com (+32 485 491 494).

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