Senior Outsourcing Associate
Department: Clinical Immunology - Research & Development Job
The Senior Outsourcing Associate is responsible for the feasibility and qualification process of clinical sample processing laboratories (SPLs) and oversees the lab assay outsourcing process by supporting Request For Proposal process, vendor contracting and managing sample logistics.
Areas of Full Responsibility
* Manage vendors responsible for Sample Processing Lab (SPL) qualification
* Assess the feasibility of SPLs selected for clinical sample processing on clinical samples
* Ensure sufficient quality of processed clinical samples before qualification of the SPLs
* Perform qualification of selected SPLs on request of Global Clinical Operations (e.g. review data, request in-house training, assess on-site training in PBMC isolation as relevant)
* Managing the realization of vendor contracts in a timely manner
* Liaise with functional groups such as, Covance on site liaison, Clinical Immunology Project leaders, Clinical Immunology Scientists, Biomarker Leads, Global Clinical Operations managers. Collaborate with external SPL's and lab vendors.
* Involved in lean projects to support Operational processes within CI (support the continuous improvement)
* Setup trial specific sample flow and SOW with Sample analyzing Labs.
* Ensure correct volumes, tubes, sample flow, sample processing.
Areas of Support
* Support vendor RFP process
* Monitor SPL sample quality
* Training of SPL personnel on clinical sample processing by advising and/or on-site training
* Provide on-site training in PBMC isolation as required
* Build and maintain internal and external network to continuously improve processes
* Provide lean process improvement guidance to improvement initiatives
* Accomplishment of targets
* Accuracy and reliability
* Planning, overview
* Quality of reports
* Innovating capabilities
* Communication capabilities
* Managerial capabilities (i.e. initiative and follow-up, priority setting, process improvement)
* Personal targets
Skills and experience sought:
* Master of Science or equivalent level (preferred)of BSc with experience, No PhD's.
* Vendor Management skills
* Must have experience in (research) project management
* Must have industry experience
* Must have strong communicative skills in English (Dutch not important)
* Training skills
* International exposure (preferred)
If you match the job description and would like to apply, or would want to hear more in general, please send me a message with your most recent CV at: j.vanbaalen(@)progressive-nl.com