When you join IQVIA as a sponsor-dedicated Outsourcing Coordinator for Clinical Supply Chain, in a home-based setting in Belgium, Poland, Spain or United Kingdom, you will enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients.
You will be responsible for the project management and serve as the primary point of contact between the sponsor and packaging and labelling vendors from the point where orders are requested to kit shipments to depots.
You will keep vendor oversight, obtain quotes, timelines and negotiation deliverables with the vendor. Furthermore, you will lead the operations meetings, work closely with the Clinical Supply Coordination teams, obtain components, and ensure labels are designed, created and printed by label vendors. Besides reviewing and approving quotes and invoices, you will also be responsible for supporting audits performed by agencies and creation of SOPs.
Your responsibilities will include:
- Creates and maintains the individual project agreements between Clinical Supply Coordination and P&L vendors.
- Obtains, reviews and approves quotes and invoices.
- Lead the operational meeting per compound ensuing all deliverables are communicated to the e.g. Clinical Scene Investigator, Manufacturing Science and Technology teams, and Supply Chain Manager.
- Negotiates timelines and oversees the project progress to ensure timely release and distribution of the clinical material to depots.
- Collaborates within the Clinical Supply Coordination team and influencing stakeholders to improve services, costs or lead time.
- Responsible for the creation, design and printing of different label types.
- Collaborates with Manufacturing Science and Technology teams to ensure equipment, pack types and labels meet the requirements of the team.
- Review and approve relevant parts of source documentation (IMPA, IPA SLED).
- Facilitates the weekly oversight of vendors and ensures the forecasted projects meet timelines.
- Supports the release of clinical trial material.
- Oversees P&L budget, inventory oversight, and destruction of clinical studies (e.g. receiving, packaging, inventory).
- Develop strong internal collaboration within Clinical Supply Coordination team and with the vendors to ensure customer satisfaction.
- Develop excellent working relationships with the other groups within Supply Management.
- Manage the outsourced packaging and labelling activities required to meet First-Patient-In date of clinical trials.
- Ensues tracking of project timelines updated in a timely manner.
- Primary contact for assigned orders, engaging with Project Managers, Quality Assurance and other staff throughout the life of the trial (documentation, meetings, quality communication, etc.).
- Manage events, deviations and CAPAs and implement process improvements (route cause analysis, corrective ad preventive actions, impact assessments, organize training, update SOPs).
- Manage all aspects of issue escalation and resolution at the vendor site and internally e.g. with Quality Assurance.
- Escalate any timeline issues and any process issues with the vendor through management and any escalation teams as necessary.
- Adheres to applicable internal and sponsor SOPs, work instructions and technical documents.
- May contribute as a mentor to less experiences Outsourcing Coordinators or to process improvement and training, as appropriate for business needs.
- May be required to support other functional tasks as required.
Qualifications:
- Bachelor’s or higher-level university degree preferable in life sciences.
- Minimum of 6 years’ experience in clinical research, including at least 4 years’ experience in a clinical supply chain management related role.
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as well as local regulations.
- Ability to an independent execution and project management oversight of outsourced packaging and labeling orders and an independent process leadership.
- Depth knowledge with packaging types, labeling, and project management services.
- Experience with the following functions preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management.
- Fluent language skills in English.
- Very good IT skills.
- Ability to work independently, effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Please apply with your English CV
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
