The Clinical Sample Manager acts as the primary contact for all clinical trial sample-related questions. This role involves creating and managing trial-specific templates, ensuring consistent documentation, overseeing research requests, coordinating long-term storage for approved leftovers, and driving process improvements.

Main activities are:
- Serve as key contact for all clinical trial sample related activities/questions towards the external labs, the internal team as well as during inspections and audits.
- Review of the sample related paragraphs in the study documents and ensure, where needed, consistency across the different studies.
- Responsible to create study-specific sample tracking file. Ensure that this file is kept up-to-date to reflect the status of the samples taken as well as their location.
- Ensure follow up of missing samples.
- Coordinate the shipment of samples from the central lab to the satellite labs in line with reconciliation activities.
- Track, per subject, what they agreed upon in their Informed Consent with regards to (future) analysis of their samples. In case a subject withdraws his/her consent or a sample is taken not according to protocol: make sure that the central and satellite lab(s) are informed about what is to be done with the samples of such a subject. Ensure that what is done, is tracked.
- Ensure that any request of research on clinical trial samples during the clinical trial is in line with the company’s additional research procedure.
- Ensure that at the end of the trial a decision is taken with regards to storing or destroying the remaining samples. Ensure that the status is tracked in the sample tracking file. Ensure that what is to be done, is in line with what is in the Informed Consent of the respective individual subjects and regulations.
- Participate in workshops to improve processes related to the function.
Qualifications
- Bachelor’s degree or University degree – medical or paramedical (pharmacy, Biology, veterinary etc.) or equivalent by experience.
- Minimum 1 year experience in similar position or position within GCP clinical trial setting.
- Biotech experience is a plus.
- Knowledge of ICH-GCP and other applicable legislation.
- Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, excel, eCRF databases, LIMS).
- Excellent Project Management, Time Management and organizational skills.
- Ability to work both independently and as part of a multidisciplinary team.
- Analytical mindset with a data-driven approach to problem-solving and decision-making.
What we offer:
- We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
- We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
- Side activities will be organised regularly, to achieve a close collaboration within our team
- We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
- We contribute to a number of charities & support the research and / or the patients in our industry.