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Clinical Project Manager with a background in GMP and Clinical Supply Chain

Employer
Syneos Health
Location
Client-Based, BEL
Salary
Competitive
Start date
14 Jun 2021
Closing date
13 Jul 2021

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Job Details

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. We bring together more than 25,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world.

For our client, a global pharmaceutical organization we are currently looking for a Clinical Project Manager with a strong background in GMP and Clinical Supply Chain. In this role you will be working from the Client's office in Rixensart but you are allowed to work from home a few days per week once you are fully trained.

In this role you will support the design and implementation of systems and processes within the TRD manufacturing & Clinical Supply organization of our client. This includes continuous improvement of the manufacturing & clinical supply processes & systems, facilities and technologies. The scope of this challenging function includes supporting Manufacture and supply management from development through technical transfer across all systems, as needed.

  • Lead key projects as assigned; this includes all prioritized projects, such as strategic needs, facility improvements, product, system and process projects.
  • Support manufacturing and clinical supply management through documentation, process review, authoring; change control generation/closure; SOP/WKI updates/generation; etc. to ensure the success introduction of new/improved products and processes into the department as needed. Interact with all stakeholders inside and outside of the organization.
  • Work across TRD Manufacturing and external stakeholders (eg clinical) to deliver systems (SOP's, WKI) which directly support Development, Phase I, II and III Clinical Manufacturing and clinical study activities in an efficient, flexible, compliant manner.
  • Implement and manage the KPI strategy for the department, which will track and report on quality, performance and personnel metrics; proactively use these KPI's to prevent issues, continuously improve the business, and communicate needs to leadership.
  • Support manufacturing and clinical supplies, supervision, management, etc., as needed to cover departmental priorities
  • Support the risk management process and own remediation plans.
The ideal candidate has:

  • Minimum education Bachelor or University degree
  • Critical success factor for role includes strong project management skills and clinical supply experience (specifically within the pharmaceutical industry); communication (across multiple layers of management); agility managing and delivering in a matrixed environment.
  • Quality/ GMP/GCP, Project Management (pharmaceutical experience),
  • Individual, working autonomously, must be capable of championing specific initiatives and collaborating with several functions.
  • Fluency in English.
  • Effective oral, written and interpersonal communication skills.

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