Purpose of the function
* Serve as a key reference contact for all clinical trial sample related questions.
* Create the trial specific templates and ensures timely completion and follow-up thereof, works together with the therapeutic indication/clinical trial team to agree and follow-up on what to do with the samples remaining after the trial specific analyses (left-overs and back-ups), where to store and what analyses to be performed/are allowed.
* Review the sample related paragraphs in the study documents and ensures consistency across the different studies, where needed
* Ensure that any request of research on clinical trial samples during the clinical trial is in line with the company's additional research procedure.
* Bring the leftover samples which are allowed to be kept and are of interest for the company, to the long term storage vendor.
* Participate in workshops to improve processes related to the function.
Responsibilities
* Provide 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.
* 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.