Sr. Clinical Drug Supply Manager

Job Description

Job Description

Salary : $192,807 - $217,321

PURPOSE OF JOB :

The Senior Clinical Drug Supply Manager is responsible for leading and maintaining clinical drug supplies, facilitating operations at both the program level and protocol level, and ensuring drug supply milestones are met. This includes responsibility for phase I-IV clinical trials, Investigator Sponsored Trials and Managed Access Programs as appropriate.

The primary focus is on drug inventory management and drug supply planning. This role will coordinate with drug manufacturing, quality, regulatory and clinical teams, and external vendors and Interactive Randomization Technology (IRT) providers.

The Senior Clinical Drug Supply Manager acts as the key member for drug supply management in the study team.

MAJOR DUTIES AND RESPONSIBILITIES :

• Defines the drug kit design, taking into account the technology, regulatory and logistic constraints with the manufacturer
• Creates forecasts and production plan to guarantee that the drug supply is in accordance with the project requirements
• Initiates packaging campaigns with the manufacturer and provides oversight to ensure on-time drug supply to sites or through local depots
• Manages shipment and delivery of drug kits and works with appropriate internal and external parties to address any issues which might impact the timely delivery of supplies to distribution depots and clinical trial sites
• Adjusts resupply strategies and production plan to optimize supply and to reduce waste by assessing clinical protocol revisions, analyzing enrollment rates, inventory usage and trends
• Supports drug expiry date management by identifying inventory to be extended, supporting the extension process and updating IRT status as appropriate
• Provides input for protocol development / amendment as needed and translates clinical trial protocols into operational demand to create and execute an effective clinical trial drug supply chain solution
• Supports the IRT assessment, vendor selection, system specifications review & user acceptance testing (UAT)
• Monitors IRT vendor and reviews IRT strategy / update to ensure it supports the approved supply plans, the recruitment needs and any protocol amendment
• Accountable for clinical supply vendor oversight as assigned
• Supports the department budget including review & approval of assigned vendor invoices and monitoring the planned vs. actual spend on trial levels
• Proactively identifies potential clinical drug supply issues, provides analysis and recommends solutions
• Coordinates and documents drug return and destruction process
• Responsible for working cross-functionally to ensure internal communication regarding scope of drug supply management
• Participates in CMC meetings to help manage expectations and ensure clear communication
• Actively participates in Study Team meetings, providing up-to-date and concise information on study progress from the clinical logistics perspective, identifying important logistic issues that require input from the Team and proposing solutions
• May be involved in the oversight of other centralized activities externalized to Service providers, depending on study needs
• Ensures study related key documents are accurate and available in e-TMF
• Maintains quality and compliance with all applicable regulations through all activities

EDUCATION REQUIREMENTS :

EXPERIENCE REQUIREMENTS :

OTHER QUALIFICATIONS :