Contractor C.T. Distribution Material Coordinator

Keywords Studios•Indianapolis, IN

5d•Onsite

About The Position

The Contractor Distribution Material Coordinator (DMC) ensures that clinical trial materials are delivered to patients on time and in optimal condition worldwide, leveraging a network of third-party distribution partners. The role is critical in supporting the approval of new drugs by ensuring robust documentation and addressing any patient risk, such as drug shortages or quality issues, as the top priority. The contractor DMC is responsible for the compliant and timely movement of clinical trial materials—from initial reception at distribution hubs, through transfers to other hubs or depots, and finally to clinical sites. This includes overseeing material management during all hub/depot operations. The contractor DMC supports supply chain planning and execution using SAP and other systems, collaborating closely with Distribution Buyer/Planners and cross-functional teams (Quality, External Partners, Supply Planning, etc.) to maintain operational excellence and regulatory compliance.

Requirements

Experience in managing inventory/supplies or complex supply chains
Knowledge of clinical trial distribution, cGMP and experience in a highly regulated environment
Customer and process focused
Demonstrated exemplary teamwork/interpersonal skills
Strong organization and self-management skills
Ability to use and apply multiple computer applications
Ability to manage multiple tasks and respond to change
Effective written and verbal communication skills in multi-cultural settings
High initiative, flexible and positive attitude
High degree of accuracy with work and attentive to details
Ability to proactively identify problems and work toward a solution
Understands global shipping requirements, including country-specific requirements

Nice To Haves

Knowledge of global import/export requirements
Clinical research/study expertise
Prior experience with SAP

Responsibilities

Oversee all operations performed by hubs/depots, including reception, shipments, labelling and inventory management, in partnership with Quality, Clinical, and hub/depot teams.
Collaborate with cross-functional teams to understand delivery schedules and priorities, ensuring timely fulfillment at hubs/depots.
Monitor SAP/KorberOne delivery lists, resolve shipment issues, and conduct investigations as needed.
Approve Quality Notification Forms from Collaboration Partners (CPs) and create internal records per procedural requirements (e.g.: external deviations, CART, distribution complaints, change controls).
Keep accuracy and consistency across SAP, KorberOne, and IWRS systems, addressing system message or interface issues.
Participate in the creation, update, and training of clinical trial distribution processes.
Maintain distribution networks diagrams and P-Info records.
Push Outbound Deliveries (OBD) from SAP to KorberOne as required.
Create purchase orders and review/approve invoices for distribution vendors as required.
Ensure completion of any pre-shipment paperwork and ensure necessary import requirements are in place prior to shipment execution
Proactively identify and implement improvements in daily activities to support productivity, efficiency, and risk reduction.
Make FFU (Fit For Use) determinations in case of temperature excursions.
Author deviations and change controls and perform investigations as necessary to address departures from SOPs.
Participate in the creation and update of clinical trial distribution processes and provide training to clients.
Support efforts and projects to improve productivity, efficiency, product quality, and risk reduction or linked to distribution process change.
Ensure material set-up in KorberOne for items not packaged by Product Delivery.
Participate in visits to hubs/depots and affiliates and support conference calls/meeting as needed
Participate in projects linked to distribution process changes, including associated change controls.
Ensure compliance with GMP/GDP and all internal/external regulatory requirements for importation, warehousing, labeling, and distribution activities for all product types.
Ensure all activities comply with company safety, environmental, and confidentiality requirements.
Maintain up-to-date individual training plans and follow procedures applicable to the clinical trial business.