**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover impactful work**
Performs site management and other related activities on assigned Cell & Gene Therapies projects in accordance with the approved protocols, ICH-GCP, GMP and GDP guidelines, applicable regulations and the organization's SOPs. Serves as a central point of contact focused on communication, site training, patient sample management, logistics (collection/shipments), analysis, and data management to provide seamless integration across patients, clinical sites/investigators, manufacturers and logistics partners. The primary role is to coordinate the process of the clinical cellular material from harvest/production to infusion between the sponsor, manufacturer, logistics vendors and investigator sites while ensuring that the chain of identity and chain of custody are intact in order to protect the patient's safety. Works proactively and independently, requiring no or mínimal supervision. Supports the line manager to mentor, train and contribute to the development of junior team members.
**The role**
We are seeking a **(Senior) Clinical Logistics Monitor**in our **Integral Clinical Supplies team** in the **EMEA region**. The role can be fully remote or office/hybrid.
**A day in the life**
- Acts as the primary point of contact for all clinical sites and the sponsor(s)
- Remote role which oversees recruitment and slot allocation on the study.
- Trains, supports and manages study sites, from site qualification through patient enrolment.
- Acts as lead support for Mock Run activities for cellular material harvest and patient sample/ IP shipments.
- Provides clinical site personnel training including refresher training on logistics activities.
- Oversees and coordinates the collection, processing, shipment to/from the manufacturing site and return of the patient’s cells for infusion including quality review and distribution of all forms.
- Oversees the material inventory (e.g., tumor harvest reagents and laboratory kits, co-therapy supplies etc. ) at the site(s) and coordinate re-ordering as necessary.
- Tracks all samples and potential patients via the organization systems or sponsor systems (if possible) or tools developed specifically for the sponsor and the study (i.e. vendor platform or cellular tracking flow sheet).
- Liaises closely with all internal and external stakeholders, including Sponsor, investigator sites, Medical Monitor, the organization's Central Labs (or outsourced vendor), the organization's Project Delivery Lead, CMO and shipping/logistics vendor.
- Assists with projects as assigned. - Supports the development of SOPs and specific training materials.
- Occasionally attends bid defense meetings.
**Keys to success**
**Education and Experience**:
- Bachelor's degree in a science-related field or Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience of clinical trials and site monitoring, 5+ years that provide knowledge, skills, and abilities to perform the job.
- This includes experience working with clinical sites and familiarity with patient sample management, logistics processes (collection/shipments) associated with the IP.
- Cell & Gene Therapy experience preferred but not mandatory.
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._
**Knowledge, Skills and Abilities**:
- Excellent medical/therapeutic area knowledge and solid understanding of medical terminology
- Understanding of trial climate and ability to predict outcomes
- Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and the organization's procedural documents
- Ability to advise, train and mentor investigational site personnel
- Excellent English and communication skills, both written and verbal
- Advanced communication, organization skills and attention to detail
- Pro-active, ability to prioritize and work in a fast-paced environment
- Willingness to learn and adapt
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