Location: Indianapolis, Indiana

Payrate: $27.00 an hour

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.

Key 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.

Requirements

Educational Requirements:

• Bachelor degree, preferably in health care or supply chain/logistics field or equivalent work experience.

Experience 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

Additional Preferences:

• Knowledge of global import/export requirements

• Clinical research/study expertise

• Prior experience with SAP

Additional Information/Requirements:

• Work outside of core hours may be required to support the portfolio across the globe

• Minimal travel may be required, both domestic and international

Benefits

Keywords provides all its contingent workforce with:

Medical, dental and vision benefits

Paid time off (including sick and select holidays)

401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Role Information: EN

Studio: Keywords Studios

Location: Indianapolis, IN

Area of Work: CTD

Service: Distribution

Employment Type: Contractor

Working Pattern: Full Time

This Organization Participates in E-Verify

Keywords Studios is committed to fair and ethical hiring practices. We expect candidates to conduct themselves with honesty and to participate in all applications and interviews independently, presenting their own knowledge and experience. Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process