Clinical Trial Supply Assistant
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Feb 25, 2021
Last Date
Mar 25, 2021
Location(s)

Job Description

Would you be excited about developing best-in-class therapeutics addressing unmet medical needs? Do you want to be part of building a leading fully integrated rare disease company providing a meaningful improvement in patients’ lives? Then take a look at this position.

As Clinical Trial Supply Assistant at Ascendis Pharma you will be responsible for managing shipping and storage temperatures and managing temperature excursions for Investigational Medicinal Products in clinical trials.

You will work closely with devoted colleagues throughout the organization, who all share the overall goal of developing and bringing new, innovative medicines to patients. The supply chain relies entirely on third party manufacturing, transportation, and warehousing. As a Clinical Trial Supply Assistant, you will be part of a dedicated and highly experienced Clinical Trial Supply team currently consisting of 12 people.

Your main tasks are:

  • Responsible for managing temperature excursions during shipment and storage of investigational products
  • Prepare and maintain storage overviews and shipment trackers
  • Planning, sourcing and ensuring temperature logging equipment for investigational sites
  • Creating/preparing questionnaires for our investigational sites and following up on their temperature monitoring systems and facilities
  • Monitoring the temperature at our investigational sites via a cloud temperature monitoring system
  • Archive in Veeva QMS and eTMF
  • Elaboration and reviewing internal SOPs and deviations
  • Collaborate with internal and external parties to ensure smooth handling of temperature excursions e.g. CMC, Clinical Operations and QA

You must have a minimum of 3 years of experience working in a GMP/GDP regulated environment and preferably with clinical trial supplies. You are proficient in English and Danish at a professional level, both written and spoken, and you master Microsoft Office, hereunder Excel. Knowledge of IRT is an advantage but not a requirement.

Ideally, you have a scientific background as pharmaconomist, lab technician or the like, and have more than 3 years of relevant work experience, preferably from biotech or the pharmaceutical industry.

You are a person with a positive attitude and you possess good communication and collaboration skills, which enable you to establish warm and respectful professional relations internally and externally. You are comfortable in a dynamic environment in which priorities may quickly change. You like working in a highly regulated area. Finally, you have a personal commitment to delivering results and succeed.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international NASDAQ listed company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy, and you will work with highly skilled and experienced colleagues to advance the company’s exciting product pipeline.

Travelling: 3 days/year

Domicile: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup.

For more details about the job or the company, please contact Annette Bested Toft, Vice President Clinical Trial Supply, Ascendis Pharma on M: +45 50 72 85 54. All applications must be in English and are treated confidentially.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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