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Clinical Trial Assistant - Biotech - Liège

Company

Our client is a clinical-stage biotech company pioneering the development of a new class of active, specific immunotherapeutics known as ImotopesTM. Their innovative technology platform is based on the discovery of modified synthetic peptides that induce specific CD4 T-cells able to eliminate the pathogenic immune cells causing autoimmune diseases. ImotopesTM hold the promise to cure patients suffering from severe chronic autoimmune diseases for which there is no adequate therapeutic alternative. Currently, a phase 2 clinical study is ongoing in type-1 diabetes and we are reaching completion of preclinical development in multiple sclerosis while projects in several other autoimmune diseases are at an earlier stage of development. We are a highly dynamic world-class team dedicated to utilizing our unique Imotope™ technology platform to improve the lives of patients suffering from these debilitating diseases.

Role

Within the Clinical Department, the Clinical Trial Assistant (CTA) is involved in the conduct of clinical studies for one (or more) project(s). He/She interacts with the Clinical Project Manager (CPM) in daily operational aspects of clinical trial management. The CTA also supports the clinical team by providing administration and project tracking support like creating and distributing study team meeting materials, completing budget related tools and documents or coordinating certain clinical trial activities with internal and external stakeholders

  • Accountable to provide general administrative support to the Clinical Department and assistance to CPM & VP Clinical and Regulatory.
  • Assist the Clinical team in completion of all required tasks to meet departmental and project goals
  • Ability to develop or use existing tracking tools.
  • Assist Clinical team with study specific documentation and guidelines as appropriate.
  • Collecting, registering and archiving information and clinical study documentation (e.g. Main Study Files, CRFs, etc.) in accordance with the applicable GCP guidelines for clinical studies
  • Be familiar with the roles of the Clinical Research Associates (CRA) ideally in site co-monitoring visits, if appropriate.
  • Coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
  • Process and track payments to vendors and study sites as appropriate.
  • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors.
  • Generate, finalize and distribute study team agendas and meeting minutes.

Profile

  • Bachelor's degree ideally in a life sciences related field or equivalent experience. You are quality oriented, a problem solver, flexible and team player
  • Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team
  • Very Knowledgeable with applicable ICH-GCP requirements.
  • Expertise in eTMF.
  • Proficiency in office suite and particularly Microsoft Excel and PowerPoint.
  • Familiar with various roles within clinical operations, such as a CRA role and PM.
  • Good organizational skills, ability to manage multiple tasks.
  • Meticulous attention to detail.
  • Excellent oral and written communication, organizational and planning skills.
  • Ability to work autonomously
  • Team oriented with excellent interpersonal skills
  • Excellent knowledge of GCP
  • At least 2-3 years’ experience as a CTA (or comparable operating experience) in either pharmaceutical industry or biotech

Offer

Working conditions: Office work - Home working (maximum 3 days/week).

This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.

We offer a permanent position in an innovating and dynamic company located near Liège and an attractive salary package in line with the position responsibilities and your experience.

Publication date

27.12.2021

Contact person

Leonard

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