Clinical Sample Manager
Job description
Are you passionate about clinical research and meticulous in managing clinical trial samples? We are seeking a dedicated Clinical Sample Manager to join our client's team. This role is pivotal in ensuring the seamless handling and tracking of clinical trial samples, contributing to the success of research endeavors.
Responsibilities
Purpose:
- Act as the primary contact for all questions related to clinical trial samples.
- Assist the Clinical Trial Manager with the set-up at the central lab (specifications, documents,..)
- Develop trial-specific templates and ensure their timely completion and follow-up. Collaborate with the therapeutic indication/clinical trial team to decide on the handling of leftover samples after trial-specific analyses, including storage and permissible analyses.
- Review sample-related sections in study documents and ensure consistency across different studies as needed.
- Ensure that any research requests involving clinical trial samples during the trial comply with the additional research procedures.
- Together with the Lead Trial Operations Excellence, transfer leftover samples that are allowed to be kept and are of interest to long-term storage vendors.
- Participate in workshops to improve processes related to the position.
Responsibilities:
- Serve as the main contact for all activities/questions related to clinical trial samples, addressing external labs, the internal team, and during inspections and audits.
- Review sample-related sections in study documents and ensure consistency across different studies as needed.
- Responsible for creating study-specific sample tracking files and ensuring these files are kept up-to-date to reflect the status and location of samples.
- Follow up on missing samples.
- Coordinate the shipment of samples from the central lab to satellite labs in line with reconciliation activities.
- Track each subject's agreement in their Informed Consent regarding the (future) analysis of their samples. If a subject withdraws consent or a sample is taken not according to protocol, ensure the central and satellite labs are informed about the required actions for the samples of such a subject and that these actions are tracked.
- Ensure that any research requests involving clinical trial samples during the trial comply with the additional research procedures.
- Ensure that at the end of the trial, a decision is made regarding the storage or destruction of remaining samples. Track the status in the sample tracking file and ensure actions are in line with the Informed Consent of the respective subjects and regulations.
- Participate in workshops to improve processes related to the position.
Profile
Skills:
- 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.
- Experience in sample management and set-up and follow-up of clinical trials
- 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.
Education and experience:
- Bachelor's degree or university degree in medical or paramedical fields (pharmacy, biology, veterinary science, etc.) or equivalent through experience.
- Minimum of 1 year of experience in a similar position or within a GCP clinical trial setting.
- Biotech experience is a plus.
Our offer
- An attractive salary in line with your experience and skills
- Fringe benefits including a company car, meal allowance, medical insurance, pension plan and a care plan
- A supporting environment
- Respect for the life-work balance
- Career planning
- A focus on professional and personal growth through training and coaching
- Room for personal engagement to help shape our company's future
Location
Gent
Evelien
Van Eecke
Clinical Talent Specialist
Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.
+32 476 98 62 94
evelien.vaneecke@fern-valley.com