Study Director / Breda

Organisatie: Eurofins
Locatie: Breda
Functie: Study Director
Vervaldatum: 29/04/2021
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Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins Central Laboratory is a dynamic, global organization fully dedicated to providing standardized, high quality global central laboratory services to support all phases of clinical trials. We are one of the industry’s leading central laboratories worldwide, supporting clinical trials in more than 50 countries across six continents.

Eurofins offers the synergy of integrating all laboratory testing services including clinical safety and specialized testing, biomarkers, bioanalysis of small and large molecules, immunogenicity testing, genomics and infectious disease services. Eurofins supports its customers with wholly owned, globally harmonized central laboratory facilities located in the US, Europe, Singapore, China and India.

Job Description

  • You are responsible for managing biomarker studies as part of clinical trials according to the regulatory requirements (FDA/EMA/GCLP);
  • You check the scope of work and budget accurately to achieve client expectations at all times;
  • You define project milestones and check project performance against protocol, from signed contract to invoice paid;
  • You monitor assay performance of various different methods, such as ligand binding assays, LC-MS/MS and flow cytometry methods
  • You control if the project is conducted in accordance with set global standards and procedures;
  • You complete and archive study files to pass prevailing regulatory inspections;
  • You support sponsor and internal audits
  • Qualifications

  • You have at least a Master’s degree in Biochemistry/ Life Sciences or a Bachelor degree in Biochemistry/Life sciences along with 5-10 years of industry experience;
  • You have a minimum of 2 years experience with G(C)LP;
  • You have a minimum of 2 years relevant regulatory biomarker experience with a CRO or pharmaceutical company;
  • You have a minimum of 2 years experience in performing or monitoring assays in the laboratory
  • You are able to work accurately;
  • You have a strong customer focus;
  • You have excellent communication and interpersonal skills;
  • You have good skills in Microsoft Office, experience with a LIMS system is an advantage;
  • You are good at establishing and maintaining internal and external relationships;
  • You are energetic and enthusiastic with a flexible and dynamic work ethic;
  • You have the appropriate personality skill set; asks when – where – what – how?
  • You have an excellent command English, spoken and written. Speaking Dutch is an advantage.
  • Categorieën: Vacatures
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