Clinical Trial Supply Manager

One of our clients, an international company in the pharmaceutical industry currently requires a Clinical Trial Supply Manager

Start: ASAP
Length: min. 6 months
Location: South of Brussels

FUNCTION DESCRIPTION

The Clinial Trial Supply Manager (CTSM) is the main point of contact for clinical supplies between
Clinical Operations and the Clinical Trial Supply Unit (CTSU).

The CTSM is responsible for the supplies used in clinical trial from start to end, from forecasting
until primary shipment delivery.

KEY RESPONSIBILITIES

Lead the Forecasting process in close collaboration with Clinical Operations, Technical
Regulatory and other functions as applicable. This includes forecasting data management,
defining the agenda for and leading the Clinical Supply TeamMeetings

Coordinate the feasibility assessment and risk analysis/mitigation at Forecasting level, Study
level and Country level

Define - in collaboration - the packaging and randomisation strategy
Define - in collaboration - the shipment and resupply strategy
Define - in collaboration - the labelling strategy
Coordinate the Demand Management in SAP
Coordinate the Demand Management of any non-standard study-related requests outside SAP
Review any study specific procedures, documents, presentations,
Assess and find agreement on delivery needs with client and communicate corresponding timelines and any changes to the delivery dates to the client
Ensure operational activities are timely included and updated asapplicable in Network Planning
Clinical Lot Demand Management: Based on existing stock, define the need for a lot production. Gather the required data from the requester; Align production/release dates with submission and/or packaging activities
Request to the Sourcing Team lot extensions in alignment with submission & packaging activities
Commercial/Competitor Vaccine and Material Management: Align requisition/release dates with submission and/or packaging activities
Follow-up of shipment delivery to ensure good receipt of shipment
Point of Contact for study related questions, process clarifications/deviations, training needs, complaints, quality,
Participation in projects as lead or contributor as assigned by Management
Audit Coordination (study related)
Continuous improvement: raise process & technology improvements, development
Coordinate SOP deviations (study-related)
Process knowledge: assure standard process knowledge as defined by Experts

PREREQUISITES

Education

Master degree in Sciences or equivalent

Knowledge

Excellent knowledge of written & spoken English - knowledge of French is an asset.

Experience

At least 5 years' experience in Project Management
Experience in Clinical Trials and/or Drug Supply Management is an asset

Skill Sets:

Core Competencies: Customer Orientation
Functional Competencies: Protocol & Study Set-up
Individual Competencies: Role Flexibility, Planning, Analytical Thinking, Problem Solving
People Competencies: Motivating, Effective Communication Project Management, Coordinating

Tags: clinical, supply, packaging, forecasting, clinical trial, pharmaceutical