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