PlusOne

Clinical Trial Assistant - Biotechnology - Liège

Company

Our client is a clinical stage biotechnology company developing a pipeline of vaccines and immunotherapies based on its proprietary technology. One of its mission is to revolutionize influenza prevention with a universal flu vaccine currently in phase 2a covering both current and future influenza infections. To reinforce their team, they are looking for a Clinical Trial Assistant for a permanent position in Liège.

Role

MAIN RESPONSIBILITIES

The Clinical Trial Assistant (CTA) is responsible for providing administrative and technical support, including regulatory activities linked to EU and US to the Clinical Operations Team and assists them with the in-house organization and the management of Clinical Trial activities. He/she will contribute to achieving successful delivery of the Company’s clinical activities by meeting company and regulatory requirements according to time, quality/scope and budget constraints, in coordination with other stakeholders in the clinical and other departments, vendors or subcontractors. The Clinical Trial Assistant will be functionally reporting to the Clinical Operations Director who acts as his/her line manager.

OTHER RESPONSIBILITIES

Trial Management

  • Maintains tracking information and reference tools for clinical trial activities
  • Assists with coordination of meetings and travel arrangements
  • Attends team meetings and prepares accurate meeting minutes and log of action items
  • Provides support for trial budget follow-up
  • Maintains oversight of the purchase order process for clinical trial supplies and
  • services, from set-up to reconciliation, as well as the processing of study invoices
  • Coordinates the ordering, packaging, shipping and tracking of clinical trial supplies and materials
  • Contributes to the overall quality of the clinical trials and key deliverables to be met
  • Administrative office support

Trial Documentation

  • Responsible for Trial Master File (TMF) management from creation to archiving, under the Clinical Project Manager’s accountability
  • Supports Clinical Operations Team by handling other Trial documentation (Essential Documents, training records and other relevant documentation)
  • Supports the Clinical Project Manager (CPM) with translation of Clinical Study documents
  • Participates in the preparation of audits / inspections
  • Makes recommendations for process improvement and efficiencies

Regulatory Affairs

  • Performs final editing and formatting of regulatory documents (Protocol, Investigators’ Brochure, DSUR, Clinical Study Report, etc.)
  • Supports CPM with the Competent Authority and Ethics Committee submissions of clinical studies and related amendments
  • Maintains tracking information and reference tools with support of Regulatory for clinical trial activities linked to EC and Competent Authorities requirements

Quality Assurance

• Contributes to continuous improvement of Clinical Operations Quality System and Regulatory: Maintenance and development of Standard Operating Procedures and other quality documents (standard forms, etc.)

QUALITY / REGULATORY STANDARDS

Osivax Quality System, Basic ICH-GCP and applicable local regulations

EXTERNAL LIAISONS

Vendors/Subcontractors involved in the studies (CRO, Product Packaging Center, etc.)

INTERNAL LIAISONS

  • Clinical Operations Director
  • Chief Medical Officer
  • Clinical Team
  • Chief Regulatory Officer
  • Finance and Administration function
  • Quality Assurance Department

Profile

EXPERIENCE

  • Short or long cycle of education in life-science or healthcare related is desired
  • At least 2 years of relevant experience in clinical trial secretary in Pharma, Biotech or CRO.
  • Basic knowledge related to ICH/GCP Guidelines and applicable local regulation
  • Experience on the different stages of Clinical Trials (set-up, follow-up and closure) is an asset.
  • Experience as regulatory assistant is an asset

SKILLS AND COMPETENCES

  • Advanced level in MS Office software platform (MS Word, MS Excel, MS PowerPoint, MS Outlook).
  • Fluent in written and spoken English at professional level. Knowledge of French and/or other official national language in Belgium is an asset.
  • Self-starter; able to work independently and within a multidisciplinary team in an international and multicultural environment
  • Problem solver, flexible, organized and proactive, pragmatic
  • Sense of urgency; able to manage multiple and varied tasks and prioritize workload with attention to detail.
  • Writing skills at level of job responsibilities
  • Good communication and listening skills

Offer

If you wish to apply, you can send your application to our recruitment partner PlusOne at Thomas Léonard by email via the following address: tleonard@plusonesearch.be or at Tom Van De Woestijne by email via the following address : tvandewoestijne@plusonesearch.be

If you want more information, you can also contact 010 / 39.21.82

Only selected candidates will be contacted.

Publication date

18.11.2020

Contact person

Leonard

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