Clinical Study Supply Coordinator

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role at Vantive:

In this role, you will be responsible for coordinating the supply chain activities for clinical trials, ensuring that all necessary materials and supplies are available for the successful execution of clinical studies. This includes management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies. You will be responsible for ensuring product compliance in global clinical trials, Investigator Initiated Research studies and educational grants to internal policies and procedures, US code of Federal Regulations, EU Directives and ICH Guidelines. You will collaborate with various stakeholders, including suppliers, clinical sites, and internal teams, to ensure timely and efficient delivery of trial supplies.

What you'll do:

• Work closely with clinical teams, project managers, and other stakeholders to understand study requirements and timelines and provide regular updates on supply chain status.

• Study Documentation: Develop study specific Investigational Product Supply Plans and contribute to clinical protocol, clinical labeling documents, Pharmacy Manuals, Accountability logs, and supply-related training/instructional materials. Maintain accurate documentation and records for audit purposes.

• Coordinate the procurement, storage, staging and distribution of clinical trial supplies, including investigational products, lab kits, and other materials.

• Arrange the shipment and delivery of clinical trial supplies to various sites, ensuring compliance with regulatory requirements and timelines.

• Inventory Management: Keep track of study materials, reconcile inventory, and maintain recalibration timelines. Identify supply accountability tracking and ensure Master, Pharmacy, Subject Logs are appropriate •

• Vendor Management: Establish and maintain relationships with suppliers and vendors (e.g. clinical locker and depots). Contribute to vendor agreements and budget negotiations.

• Administrative Support: Update electronic systems, transfer data, and ensure source documents meet compliance standards

• Quality Oversight: Escalate quality concerns to the project manager and contribute to process improvements

• Ensure that all supply chain activities comply with relevant regulatory guidelines and standards, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Identify new global requirements and implement locally as studies push into different geographical regions.

• Attend Investigator Meetings and study team meetings, as needed.

• Develop and implement supply chain strategies to optimize efficiency and cost-effectiveness.

What you'll bring:

• BA/BS in scientific or logistics discipline

• 2-3 years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in Clinical Supply Management, Supply Chain Management, or a related field. International supply management a plus.

• Knowledge of US code of Federal Regulations, EU Directive and ICH Guidelines, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives.

• Experience working with third-party vendors and contractors, preferred.

• Order management and distribution process knowledge.

• Ability to maintain effectiveness under changing circumstances and priorities.

• Ability to expand knowledge and adapt to an increasingly complex environment.

• Excellent verbal and written communication, presentation, project management, interpersonal and organizational skil