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Project Manager I CMC - 6 months FTC

  1. Assen
JR117776
  1. ICON Full Service & Corporate Support
  2. Program Management
  3. Office Based

About the role

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Job title: Project Manager CMC

Location: Office based role in Assen, Netherlands

This is a maternity cover position on a 6-month fixed-term contract with the potential to transition to a permanent assignment.

Overview:

Join our team as a Project Manager in the Chemistry, Manufacturing, and Controls (CMC) department, where you manage CMC projects in the early phase development to manufacture medications for healthy volunteer and patient studies. As a Project Manager, you will work in close collaboration with our clients and together with our pharmacists and the Quality Control Lab to ensure the quality and safety of the investigational medical products. Your responsibilities will involve leading CMC projects, coordinating cross-functional teams, and ensuring compliance with regulatory standards to deliver high-quality pharmaceutical products within specified timelines and budgets.
 

Responsibilities:

  • Monitor and evaluate CMC project progress in terms of milestones, budgets, and timelines.

  • Manage CMC projects to ensure coordination with in-life project phases and proper activity tracking throughout the study duration.

  • Work with laboratory management to ensure adequate resources are available for timely completion of studies.

  • Obtain all client-specific documents required for analysis and review protocols and amendments for adherence to specifications and regulatory requirements.

  • Prepare analysis plans tailored to client needs and obtain client approval.

  • Provide regular updates to sponsors, forecasting study progress, and reporting any significant deviations.

  • Maintain records of work conducted, tracking revenue and resources associated with assigned studies.

  • Identify changes to the scope of work and ensure proper processing of change orders.

  • Review and approve all data in accordance with direction documents, ensuring compliance with GMP regulations and SOPs.

  • Initiate investigations and event deviations as necessary and address QA findings in reports.

  • Prepare reports of work conducted, address all QA findings, and ensure proper archiving of documentation upon study completion.

  • Review and approve laboratory notebooks and analytical data as required.

Qualifications:

  • A minimum of 3 years' experience in a laboratory or project management role, at the discretion of the hiring manager.

  • Strong background in project management, preferably in a bioanalytical or pharmaceutical setting.

  • Familiarity with GMP regulations and compliance requirements.

  • Excellent communication and interpersonal skills.

  • Ability to effectively manage resources and prioritize tasks to meet project deadlines.

  • Detail-oriented with strong organizational and problem-solving abilities.

  • Bachelor's or Master's degree in a relevant scientific field preferred.



Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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Department

Full Service - Development & Commercialisation Solutions

Location

Assen

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Program Management

Job Type

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Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I

Reference

JR118498

Expiry date

01/01/0001

Stephanie Broize-Arrieu Read more Shortlist Save this role

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