Supply Chain Study Lead (SCSL)
Job Description
The Supply Chain Study Lead (SCSL) is accountable for the set-up and follow-up of the logistical activities from the issue of a draft concept protocol till the overall vaccine reconciliation at study end (end-to-end supply chain). The scope of the work includes project management, leadership and oversight of both global and in country activities, as well as authorship at some study documents.
The SCSL is accountable for defining detailed demand and supply plans for investigational medicines that consistently deliver those medicines on-time to patients while ensuring the supply chain delivers results that support published study milestones.
This role is responsible for reviewing and influencing clinical protocols relative to investigational product (IP) supply and determining optimal supply plans that are patient-focused, risk-adjusted, and cost effective. Furthermore, the SCSL ensures timely execution of the plans and follows through on supply chain performance to ensure the successful delivery of the supply chain.
This role supports Phase I through IV sponsored clinical studies as well as investigator sponsored trials and compassionate use studies.
Responsabilities
- Translation of study protocols into an operational demand ;
- Feasibility assessment for completion of logistical activities ;
- Definition of logistical operational strategies (supply, distribution, randomization, ...).
- Builds and maintains strong working relationships as the primary interface with the clinical study teams.
- Works with the Supply Chain Manager to understand and support the asset-level supply strategy.
- Set-up and follow-up of clinical supply related activities for a project or a group of studies.
- Understands and challenges key assumptions and study planning parameters to ensure an optimal tradeoff across cost, risk, and benefit is achieved.
- Develops, implements, and maintains the IP supply plan for assigned studies
- Creates and maintains detailed, study specific demand and supply plans for assigned studies.
- Accountable for ensuring that label content is defined and the data is set-up in the appropriate system(s) and liaising with relevant groups on pack design and pack desgin and pack component suitability.
- Accountable for ensuring appropriate Interactive Response Technology (IRT) contract and setup is in place.
- Supports externalization activities where vendors and/or partners are included in the supply chain.
- The guaranty of alignment among the network of stakeholders, Good Manufacturing Practices (GMP) operations and clinical operations (central and local) to support deliveries and ancillaries in time at right quality and within agreed budget.
- You hold a Master's degree in Biology, Biochemistry, Chemical Engineering,
Bioengineering, Pharmacy, Logistics or other relevant discipline. - Knowledge of clinical trial study desings and approaches and their implications for supply chain
- Knowledge in the management of IP supplies and experience in inventory management.
- Demonstrated working knowledge of supply chain and planning principles
- You are fluent in English (Writting and speaking). Fluency in French will be considered an asset.
- You are based in Canada or in the USA.
- You have excellent coordination skills and have a strong and overall clinical
Project/Study knowledge. - You have strong problem-solving skills.
- Your are comfortable working on multiple and complex projects that require to be innovative and creative with regards to global supply problems
- You are familiar with IRT systems, especially with respect to supply management and patient randomization.
- Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes.
- You are familiar with Good Clinical Practices (GCP) & Good Distribution Practices (GDP).
quality standards and are totally knowledgeable about Clinical Trial Supplies
Operations (Labelling/Pack/Warehouse/Distribution). - Knowledge of SAP will be considered a strong asset.
What we offer
A unique fast-paced environment in transformation, a unique project to lead, facilitate and support dozen of initiatives to bring process optimization in our Clinical supply department.
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international
environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organization and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our human approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to deliver services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
- Department
- Consulting
- Role
- Clinical Supply Consultant
- Remote status
- Fully Remote
Workplace & Culture
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We're excited to invite you on to our successful journey with a strong human culture, where you can grow, improve, and magnify your talent.
About Keyrus Life Science North America
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Supply Chain Study Lead (SCSL)
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