Clinical Trial Supply Manager

Description

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

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

Clinical Trial Supply Project Manager

FUNCTION DESCRIPTION

The Clinial Trial Supply Manager (CTSM) is the main point of contactfor 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 Team Meetings
· 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-relatedrequests outside SAP
· Review any study specific procedures, documents, presenations, ...
· 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 withsubmission & 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 byExperts

PREREQUISITES

Education

Master degree in Sciences or equivalent

Knowledge
· Excellent knowledge of written & spoken English
· Good knowledge of French.

Experience

· At least 5 years' experience in Project Management
· Industrial experience is required
· 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, AnalyticalThinking, Problem Solving
· People Competencies: Motivating, Effective Communication, ProjectManagement, Coordinating

Tags: Supply Chain, Clinical, Clinical Trial, Supply Manager, Project Manager, pharmaceutical, Labelling