Direct message the job poster from Integrated Resources, Inc (IRI)
Lead Recruiter at Integrated Resources Inc. (IRI)
Clinical Supply Manager
Location: Remote
Duration: 12 months
Shift Timing: EST Hours
Qualifications:
- B.S. in a scientific, healthcare, or related field with 4+ years of global clinical supply chain experience within the biotechnology sector. APICS certification is advantageous.
- Proven experience in establishing, refining, and managing clinical supply chains in the biotechnology industry.
- Solid understanding of GMPs, GCPs, GDPs (GxP) requirements.
- Strong attention to detail and excellent follow-up skills.
- Knowledge of import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
- Experience managing third-party CROs and CMO clinical supply operations.
- Experience with GxP systems, including development of specifications, oversight, troubleshooting, and risk mitigation, especially with IRT systems.
- Exceptional communication skills, collaboration, and ability to manage complex challenges.
- Excellent planning and organizational skills to handle multiple projects with tight deadlines.
- Experience supporting regulatory inspections and audits as a Clinical Supply Chain SME.
- Proactive in driving cross-functional performance and fostering collaboration.
- Ability to build consensus and translate strategies into actionable plans.
- Proficient in MS Office and related tools (e.g., Smartsheet, Excel, PowerPoint, Visio, Project).
Certifications & Licenses:
- APICS certification
- CMC
- CSC
Skills:
- Oversee clinical supply activities: label generation, packaging, labeling, release, distribution, expiry extension, cold chain, inventory management.
- Ensure timely startup of studies through prompt supply availability.
- Manage clinical supply programs, including inventory and distribution in partnership with CMOs.
- Oversee global strategies in IRT systems.
- Maintain and review Clinical Supply SOPs.
- Address departmental deviations and collaborate with QA.
- Represent the company during inspections and audits.
- Develop continuous improvement plans for GMP, GDP, and business processes.
- Assist with drug accountability and inventory reconciliation.
- Provide risk mitigation recommendations.
- Manage inventory of study drugs and comparators at depots.
- Mentor team members on programs and systems.
Seniority Level:
Employment Type:
Job Function:
Industries:
- Pharmaceutical Manufacturing and Biotechnology Research