Clinical Microbiologist

For one of our client based in Wallonia, we are urgently looking for a Clinical Microbiologist

  • Do you have a Medical doctor degree or a PhD with clinical microbiology expertise and hospital lab/diagnostic lab experience?

  • Do you have strong knowledge in vaccines and microbiology?

Then this might be the ideal job for you! Don't hesitate, and apply as soon as you can!

Job Description 

Expert in clinical microbiology diagnostic assays: contribute to the clinical read-out strategy by managing the technical and scientific oversight of clinical microbiology activities in multi-countries local laboratories to support one or several vaccine development programs. Manage scientific assessment and oversight of lab activities in agreement to GxP requirements (GMP, GCP, GCLP).

Responsibilities 
  • Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role

  • Responsible for the scientific and technical oversight of clinical microbiology testing in multi-countries

  • In charge of supporting Local Operating Companies (LOC) for the initial feasibility, steps of the local lab proposal, including direct interaction with the local labs

  • Ensure fit for purpose of the methods that will be used in the epidemiological/clinical studies and develop the Analytical plan accordingly

  • Perform (or support Clinical Research Associates) the local lab quality oversight (quality of operations but not the task coordination) and will be informed/consulted about deviations at local lab potentially impacting studie

  • Ensure alignment between the analytical plan and the activities performed, including data reporting

  • Document the microbiology certification of the local labs in CLS files until study

  • Manage communication related to scientific and technical oversight with health care professionals,external partners, local representatives and Clinical Laboratory Sciences (CLS) stakeholders to follow-up on study and local lab set-up, testing progress, assay or process deviations.

  • Review assay, equipment or process deviations, define & manage CAPAs.

  • Escalate any risks and issues identified.

  • Share know-how in his/her field of competency and support others in their scientific/technical development. Present data in meetings within CLS or in front of external audience.

  • Provide support for the development and/or review of internal and external publications, documents (e.g.INDs, regulatory submissions and respond to questions from regulatory authorities during submission) and communications.

  • Participate to the follow up of collaborations with other teams/experts to share/gain scientific and technical expertise and for technology transfer within (i.e. Preclinical, QC) and outside

  • Participate to CLS and R&D knowledge management in the field of expertise.

  • Ensure all activities under responsibility are performed in compliance with Quality Assurance (QA), guidelines, relevant regulations and internal policies. Apply good documentation practices (GDP) and manage human biological specimens and raw data in agreement to the company rules.

  • Breadth/ Scope of Accountability

  • Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility.

Profile 
  • University level (Medical Doctor preferred, not exclusive)

  • English skills

  • Details oriented

  • Positive attitude

  • Strong interpersonal and influencing skills

  • Collaborative approach, trying to find solutions and consensus, sticking to the rules

  • work independently

  • Workflow / Process oriented, with a quality mindset

  • Strong organizational and negotiating skills

Contact Information 

Amandine Planche
 +32 2 588 16 07
amandine.planche@valesta.com

Application form : Clinical Microbiologist

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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
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