Patient Operations Management Associate – Contract

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee patient scheduling tools, guidelines, work instructions, and dashboards for the delivery of cell therapy products.

• Assist in tracking and reporting logistics information related to investigational products and patient metrics utilizing databases, spreadsheets, and other tools.

• Aid in the development of communication plans and templates for regular updates regarding patient status with Clinical Operations and clinical sites.

• Manage manuals and training resources for clinical sites concerning the shipment of patient materials and product receipt.

• Facilitate logistics and supply chain processes for investigational products in both domestic and international clinical trial activities.

• Support the management of vendors and systems associated with investigational product logistics in collaboration with cross-functional stakeholders.

• Participate in meetings that focus on clinical trial launches and ongoing enrollment activities.

• Work with key stakeholders to ensure a comprehensive patient journey program.

• Suggest process enhancements and advocate for collaboration and execution excellence.

• Provide training to CRO staff, clinical site personnel, and other relevant audiences as required.

• Engage in the development, review, and implementation of SOPs and processes.

• Execute other assigned duties.

⛳️ Requirements

• Bachelor’s degree or equivalent experience.

• Preferred background in the healthcare sector and experience within an FDA-regulated environment.

• Knowledge of fundamental FDA and EMA regulations, ICH guidelines, GCP, and GMP.

• Experience in clinical logistics and pharmaceutical supply chain management.

• Experience overseeing outsourced drug logistics, including warehousing, transportation, customs clearance, and invoicing.

• Familiarity with the logistics and transport of biological materials in both domestic and international contexts, adhering to IATA, ICAO, ADR, DOT, and WHO requirements.

• Exceptional interpersonal and collaboration abilities.

• Capacity to work both independently and collaboratively to achieve primary objectives.

• Strong analytical skills to devise solutions for complex issues.

• Organizational capabilities and the ability to multitask and prioritize responsibilities.

• Proficiency in supporting or leading vendor management initiatives.

• Strong work ethic, a commitment to driving change, and a passion for helping others.

• Must possess authorization to work in the U.S.

• Preference for candidates based on the East Coast.

• Willingness to eventually assist with EU operations.

🏝️ Benefits

• 100% remote work.

• Collaborative work environment.

• Opportunity to collaborate with talented individuals.