Ref #: 25565

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 26-May-2021


Services include project management and serving 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. Services/deliverables include ensuring vendor oversight, obtaining quotes, timelines and negotiation deliverables with the vendor. Lead the operations meetings, work closely with the CSC teams, obtains components, ensures labels are designed, created and printed by label vendors, reviews and approves quotes and invoices, responsible for supporting audits performed by agencies and provide business support for vendor audits, and creation of sop’s. Further, services/deliverables include partnering with Supply Chain Coordination for incoming drug product, and ID sample shipments.

Key responsibilities:

• Creates and maintains the individual project agreements (IPA) between CSC and P & L vendors.
• Obtains, reviews, and approves quotes and invoices.
• Lead the operational meeting per compound ensuing all deliverables are communicated to the LC, CSI, MST, TSM, and SCM.
• Negotiates timelines and oversees the project progress to ensure timely release and distribution of the clinical material to depots.
• Collaborates within the CSC and influencing stakeholders to improve services, cost or lead time.
• Responsible for the creation, design, and printing of different label types.
• Collaborate with MST 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 expired materials.
• Conduct issue resolution activities for supply aspects of clinical studies (e.g., receiving, packaging, inventory).
• Develop strong internal collaboration within CSC and with the vendors to ensure customer satisfaction.
• Develop excellent working relationships with the other groups within Supply Management.
• Manages the outsourced packaging and labelling activities required to meet First-Patient-In date of clinical trials.
• Ensures tracking of project timelines updated in a timely manner.
• Primary contact for assigned orders, engaging with PM’s, quality, 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 and preventive actions, impact assessment, organize training, update SOPs)
• Manages all aspects of issue escalation and resolution at the vendor site and internally with ESIQ or QA.
• Escalates any timeline issues to the RR.
• Escalates any process issues with the vendor through management and any escalation teams as necessary.
• Adheres to applicable SOPs, WIs, and technical documents
• May contribute as a mentor to a less experienced outsourcing coordinators or to process improvement and training, as appropriate for business needs.
• May be required to support other functional tasks or projects as required.

Required experience and qualifications:

• Academic degree with 2-4 years of experience in a clinical supply related role
• Autonomy in execution and project management oversight of outsourced packaging and labeling orders.
• Knowledge with packaging types, labeling, and project management services
• General knowledge of GxP principles
• Experience with the following functions preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management.
• Ability to work independently with limited coaching
• Fluent communication skills in English (Dutch is a strong plus)

Why this role is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

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