Clinical Project Manager /Lead PBMC-CRM (ID 115)

Introduction

For one of the world’s leading R&D companies, we have a great opportunity for a Clinical Project Manager / Lead PBMC to manage Early Development studies.

Experience in working in a biology, biotechnology or a cell culture lab is an asset because vendor management of specialized labs is an essential part of the job.

Organisation

Negotiates terms & conditions and price, and contracts the vendor that manages a global network of Blood-PBMC processing labs in collaboration with Procurement

Co-supervises training and (re)qualification of (newly selected) Blood-PBMC processing labs, including dry-runs / pilot studies and quality assessments of cryo-preserved PBMCs

Co-audits Blood-PBMC processing labs within the global lab network

Supervises the logistical set-up and management (by the vendor) of

  • shipments of blood samples, from blood-collection sites to Blood-PBMC processing labs
  • shipments of cryo-PBMC samples, from Blood-PBMC processing lab to central lab, Immunology lab and/or Long Term Storage facility
  • storage of cryo-PBMC samples (Liquid Nitrogen)
  • inventory of cryo-PBMC samples


Safeguards the application of one uniform PBMC Processing procedure – selected by the sponsor – across the different Blood-PBMC Processing labs

The PBMC-Study CRM has experience with working in a cell culture lab. Having experience with PBMC Harvesting and cryo-preservation is an asset.

Negotiates terms & conditions and price, and contracts a vendor that performs T-cell response assays such as but not limited to ELISpot and ICS, in collaboration with Procurement

Follows up on the qualification of the Immune-assays that will be applied in interventional studies

Supervises the logistical set-up and management (by the vendor) of

  • storage of cryo-PBMC samples (Liquid Nitrogen) in the Immunology Lab
  • analyses of cryo-PBMCs in pre-defined immune-assays


Organizes and supervises the (e)Data Transfers from the Immune-lab to the sponsor

Organizes and supervises the statistical analyses of data generated in immune-lab

Ensures a final report is created by the vendor and shared with the Clinical Development Team as appropriate according to the pre-defined timelines



Prérequis

Education and experience:

Master in Life Science – such as pharmacy, biology, biotechnology, etc

Experience in working in a biology / biotechnology / cell culture lab, is a must

Experience in early clinical development, with emphasis on Clinical Study Execution and Management, as demonstrated by the previous experience in clinical study monitoring and clinical operations support, is a must.

Team Work experience, is a must

Experience in auditing and qualifying laboratories, is an asset

Experience in working in a matrix-structured organization, is an asset


Knowledge:

PBMC Isolation + Cryo-preservation, ELISpot, ICS (Intracellular Cytokine Staining) and cytokines analyses, is an asset

Good Laboratory Practice, Good Clinical Practice and ICH Guidelines is a must

Early Development, Phase I and Phase II environment, is a must

Late Development, is an asset

Immunology (scientific knowledge), is an asset

Hepatitis B or Respiratory Disease (scientific knowledge) is an important asset

Biomarkers is an asset

Vaccine Development is an asset


Skills:

Excellent project management /organizational/logistical skills

Proactive attitude and eager to take ownership

Solid scientific reasoning skills

Excellent people management and decision-making skills

Fluent in written and spoken English with good presentation skills

Good sense of cultural sensitivities and differences

Ability to identify priorities and work under pressure to meet deadlines

Ability to advise, persuade and negotiate with external parties in a supportive and constructive fashion

Willingness to travel abroad

Willingness and ability to partially adjust work hours in order to facilitate trans-Atlantic collaborations (with USA, Asia-Pacific, …)

Located in Belgium


Sonia Vandekerkhove
Type de contrat Contract
Secteur Pharmaceutical
Pays Belgium
Famille d'emploi Clinical