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(Freelance) Clinical Project Manager

  • Ubicación:

    Gembloux, Bélgica

  • Contacto:

    Aurore Munaut

  • Tipo de trabajo:

    Contract

  • Teléfono de contacto:

    +32 10 68 53 31

  • Industrias:

    Life Sciences

  • Correo de contacto:

    aurore_munaut@oxfordcorp.com

Interested in a fantastic project opportunity as Clinical Project Manager within next generation diabetes and cardiovascular healthcare ? Apply now !

Job Description

Complete oversight and responsibility of ongoing clinical trials.

Responsibilities

  • Operational delivery of a clinical trial from start to CSR in the set timelines, within budget and with the highest achievable quality.
  • Ensuring day to day oversight and management of start-up, conduct and close-out phase of the clinical projects according to the applicable rules and regulations ( including but not limited to ICH E6 (R2), EU regulation, …)
  • Watch over progress of the clinical trials in the context of the set timelines, predefined budget and quality.
  • Ensuring development of and / or contribution to and review of all the documents needed in context of clinical research ( clinical study synopsis, protocol, project plan, monitoring plan, ICF, data management plan, clinical study report, …)
  • Monitoring and managing the study budget as defined per study contract.
  • Generating study status updates internally including management on regular basis during conduct of the clinical trials.

Requirements

  • At least 5 - 10 years of experience in clinical trial operations, preferably in international / global drug development; experience in clinical operations in food trials is considered a plus.
  • Good knowledge in ICH - GCP
  • Experience in conducting trials in metabolic health or chronic inflammation is a strong plus.
  • Strong project management skills ( proactive, planning, organized ) including experience in project managing cross-functional teams in clinical development.
  • Good communication skills.
  • Good inter-personal skills and experience in managing sites, clinical service providers and vendors.
  • Experience in Biotech environment is a plus.
  • Skilled in working with Microsoft Office programs ( ie. Word, Excel, PowerPoint, ctc.)
  • Maintains high ethical standards, including a commitment to values & policies.
  • Is aware of and sensitive to, cultural differences.
  • Fluent in English ( writing and speaking )

  • Masters or bachelor's degree in pharma, life-sciences or health related studies.
  • Experience in ( global ) drug development.
  • Existing right to work in Europe required

Benefits

  • A balanced salary package based on your capabilities and experience
  • 3 days / week (60%)
  • 5 month's project with possibility of extension
  • Hybrid work (combination of remote work and on-site work in Belgium)

Vacancy number: 20467