Description
For one of its clients located in Walloon Brabant, Harvey Nash is currently looking for a
Clinical Project Manager
Duration: 3 months (+ renewal)
Location: Walloon Brabant
Scope of work:
- Ensure appropriate internal planning & tracking of bulk DP supplies
- Ensure appropriate stock management of DP bulk and provide support during consolidation meeting with CTSO
- Enter & ensure tracking of PR, item code (not the PO) into SAP
- Ensure proper tracking of CMO, QA activities, shipping, stakeholders that review doc., samples, stability, availability DS for DP manufacturing
- Initiate & ensure tracking of all CC, OOS, deviation, CAPA management related to Clinical activities
- Business case (right scale, tooling, PP, .)
- Project portfolio review
- Quality agreement availability (creation and approval) and update
- Price negotiation
- CMO continuous improvement
- Monthly/Quaterly operational meeting
- Driving optimization of CMO network
- Risk analysis, Yearly CMO risk assessment exercise (including mitigation plan definition and follow-up)
- CMO selection & assessment, ensure appropriate network
- CDA availability (preparation, negotiate, approval)
- Definition of logistic flows
- Supply agreement : first version or renegotiation (including escalation process definition)
- Operational mgt of global strategic CMOs (dev - clinical - commercial), lead CMO vendor team, lead contact with CMO
- Maintenance CMO data base
- Annual business review meeting (preparation, execution, report, including KPI review) + periodic high level contact with CMO top management
- CMO account plan (prepare review and align with CMO)
- KPI review and definition
- CMO financial situation
Requirements:
- At least 5 years of experience in the pharmaceutical industry
- International experience a plus
- Fluent French is mandatory
- Fluent English is mandatory
Tags: clinical trial, clinical project manager
Harvey Nash is a tusted partner of Belgian pharmaceutical companies