Offer summary

Qualifications:

Bachelor's degree in a related field., 3-4 years of experience in the pharmaceutical industry, preferably in clinical supply chain., Knowledge of global clinical trials, drug development processes, and regulatory requirements (e.g. cGMP, GCP)., Strong organizational, analytical, problem-solving, and communication skills, with proficiency in MS Office Applications..

Key responsibilities:

Manage clinical supply activities for assigned clinical programs and develop supply plans.

Coordinate with Clinical Operations to align clinical demand requirements with supply plans and timelines.

Maintain communication with Investigational Material Supply Chain Integrators regarding drug product demand and supply forecasts.

Lead cross-functional clinical supply status meetings and oversee ongoing supply activities in the IRT system.

Job description

This role will support IQVIAs FSP (Functional Service Provider) offering, being 100% Sponsor-Dedicated.

Job Overview

The Manager, Clinical Supply Chain manages the clinical supply activities for assigned clinical programs. The Manager develops and maintains clinical supply plans to include investigational products and co-meds ensuring accurate and continuous supply to assigned clinical programs while reducing risk and minimizing waste.

Essential Functions

• Represent Clinical Supply Chain on Clinical Study Teams and provide a high service level to internal stakeholders.
• Works with Clinical Operations to understand clinical demand requirements and ensures alignment with study teams on clinical supply plans and timelines.
• Develop and maintain clinical supply forecasts (Within forecasting system N-Side) and inventory plans for assigned programs, ensuring alignment with upstream supply integrators.
• Maintain routine and timely communication with Investigational Material Supply Chain (IMSC) Integrators to discuss aggregate drug product demand, changes in clinical supply forecasts, and study timelines.
• Maintain routine and timely communication with Investigational Material Supply Chain (IMSC) Operations to discuss the planning and execution of all packaging and labeling work to support clinical trials.
• Coordinate sourcing of co-meds working closely with Procurement, Supply Vendors and Alliance Managers. Ensure delivery of co-meds to IMSC Operations for further packaging and distribution.
• Generate and monitor co-med budgets and spend working closely with Development Project Managers, Clinical Operations and Finance.
• Manages clinical supply inventory, develops inventory reports and monitors upcoming expiry for assigned programs.
• Align efforts among Project Management, Clinical Operations, and Technical Operations for the timing and delivery of clinical supplies for assigned programs.
• Facilitate discussions and decisions on label and packaging design, as needed.
• Support IRT user acceptance testing, develops IRT supply strategy, and oversees ongoing supply activities in the system.
• Leads cross-functional clinical supply status meetings.

Qualifications

• Bachelor degree in a related field.
• 3-4 years of work experience in the pharmaceutical industry.
• Experience in clinical supply chain is preferred.
• Knowledge of global clinical trials and the drug development process.
• Knowledge of global pharmaceutical regulatory requirements (e.g. cGMP, GCP).
• Knowledge of IRT system set-up, functionality, and proficiency with excel modeling.
• Competence with computers and technology is essential; to include extensive experience with MS Office Applications is required.
• Experience with forecasting and inventory management tools is preferred.
• Strong organizational, analytical, problem-solving, and communication skills.
• Must be a dependable self-starter and be capable of working independently on multiple projects with the ability to prioritize tasks and meet deadlines.
• Experience in vendor oversight and managing external partnerships is preferred.
• Proficient in the English language.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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