Your job as a Clinical Trial Material Manager

As a Clinical TriaI Material Manager you will actively participate in international multi-disciplinary study teams and will be responsible for management of CTM supplies to clinical studies. The major features of this job are:

• Coordinate the manufacturing and supply of clinical trial materials for multiple clinical studies (worldwide) from development till post-marketing studies in phase I - IV.
• Represent Clinical Supply Chain (CSC) in contacts with contractors and internal and external suppliers and customers.
• 'Translate' the clinical study protocol into a packaging and labeling design and set up a strategy for distribution to sites and depots worldwide.
• Set up and be main contact for Interactive Response Technology (IRT) systems used in the clinical studies.
• Prepare budget and timelines for the aforementioned activities.
• Supervise and coordinate the manufacturing and supply within the agreed design, budget and timelines.
• Participate in clinical study teams and local project teams with full responsibility for CTM related paragraphs in protocols and reports.
• Attendance of selected international meetings/congresses such as monitor and investigator meetings.

Your personal qualifications as a Clinical Trial Material Manager

• Pharmaceutical or life science background at academic level
• Preferably at least 3-5 years of experience in clinical supplies management
• Capability to operate within the quality requirements stated in the international GMP guidelines
• Flexible and open attitude towards change
• Capability to act in a global, multicultural, corporate environment with changing and different priorities
• Good English communication skills, both written and verbal

As a Clinical Trial Material Manager you have good communication and coordination skills coupled with the ability to act on own initiative for optimal support of the team activities and maintain good relationships with contractors. International travel can be part of the job.

We offer:

• A challenging and diversified job in an international setting
• Good career opportunities
• An inspiring and dynamic work climate
• Attractive remuneration, which includes:
  • a 13th month
  • excellent pension policy
  • health insurance compensation
  • collective health insurance
  • company own saving scheme arrangement
  • 25 Holidays + 13 so called ADV Days
  • and more....

At Astellas, we believe that nurturing a good relationship with our employees delivers good business results.
It is our stated aim in the VISION for Astellas to be recognized as an Employer of Choice. This means ensuring we are a highly effective organization, that applies best-in-class people management, creates a positive working environment and has an inspirational company culture. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.

Astellas

Astellas is a Japanese multinational pharmaceutical company employing about 16,500 people worldwide with global sales exceeding 10billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,200 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.

Mirai House, located in Leiden Bio Science Park, is home to a number of divisions, including the European R&D organization focusing on the development of medicines in the areas of Urology, Nephrology, Pain, and Diabetes/Metabolic diseases. It is the location where the majority of offices and clean rooms and labs are located.