Purpose of the function
* Serve as a key reference contact for all clinical trial sle 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 sles remaining after the trial specific analyses (left overs and back ups), where to store and what analyses to be performed/are allowed.
* Review the sle related paragraphs in the study documents and ensures consistency across the different studies, where needed
* Ensure that any request of research on clinical trial sles during the clinical trial is in line with the company''s additional research procedure.
* Bring the leftover sles 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 sle related activities/questions towards the external labs, the internal team as well as during inspections and audits.
* Review of the sle related paragraphs in the study documents and ensure, where needed, consistency across the different studies.
* Responsible to create study specific sle tracking file. Ensure that this file is kept up to date to reflect the status of the sles taken as well as their location.
* Ensure follow up of missing sles.
* Coordinate the shipment of sles 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 sles. In case a subject withdraws his/her consent or a sle 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 sles of such a subject. Ensure that what is done, is tracked.
* Ensure that any request of research on clinical trial sles 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 sles. Ensure that the status is tracked in the sle 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
1. Bachelors degree or University degree medical or paramedical (pharmacy, Biology, veterinary etc.) or equivalent by experience.
2. Minimum 1 year experience in similar position or position within GCP clinical trial setting.
3. Knowledge of ICH GCP and other applicable legislation.
4. Experi