• Utrecht
  • 40 uur
  • WO
solliciteer via YACHT

Clinical Study Manager


  • 24 oktober 2018
  • Utrecht
  • 40 uur
  • WO

functieomschrijving

  • 24 oktober 2018
  • vacaturenummer: 9059400

Yacht Life Sciences has a vacancy for a Clinical Study Manager at Danone - Nutricia Research.

Are you passionate to make a health difference through nutrition for infants, mothers and families by providing clinical expertise in the start-up and operational management of clinical studies? Do you get excited of translating ICH-GCP guidelines into one or more clinical studies?

Your mission: the Clinical Study Manager is responsible for the operational management of clinical research projects, including start-up, overall progress and reporting of the clinical studies, all in according with the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures.

The Clinical Study Manager will work within the Global Early Life Nutrition Center of Excellence Clinical Research. The CSM will play a crucial role in the start-up and operational management of the clinical studies. He/she will be responsible for translating the clinical study protocol into the clinical study plan and ensures that good quality data will be collected.  The CSM brings his expertise into the clinical studies, has a helicopter-view on how the studies are developing and will include colleagues or stakeholders where needed.

Other key responsibilities are:

  • Establish a smooth cooperation within the multi-disciplinary project team, consisting of CSR’s, CSA’s, Data Management, Supplies, Quality and Science
  • Ensure studies are set up and conducted in line with GCP
  • Arrange for regulatory and ethics submissions and approvals
  • Select, collaborate with and monitor activities of clinical partners (CRO’s/ sites)
  • Provide progress reporting (resources, budgets, timelines)
  • Day-to-day alignment with the team members

Functie-eisen

We are looking for a Clinical Study Manager with:

  • a Master or PhD in life science or related scientific discipline
  • solid experience in (international) clinical research in an academic setting or the (bio-) pharmaceutical industry
  • thorough knowledge of legislation and ICH-GCP guidelines
  • Project management skills
  • Excellent communication skills in English to interact with internal and external stakeholders
  • Problem solving and critical thinking capabilities
The ideal CSM is able to manage clinical studies in various stages from start-up to overall progress and reporting. He/she knows how to translate legislation and ICH-GCP into a pragmatic and hands-on approach, while staying conscious of the risks involved. He/she is able to connect effectively with various stakeholders inside the company but also externally with for instance CRO’s, central labs, sites and investigators. The CSM is someone who takes a pro-active approach in his work and can clearly distinguish main and side issues.
 

Arbeidsvoorwaarden

Secondment placement for 1 year with longer-term possibilities.
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.

Bedrijfsinformatie

Danone is a multinational food company dedicated to bringing health through food to as many people as possible. R&D is an important basis of the work they do in nutrition and health. They collaborate with partners, for example in academia, suppliers and healthcare, aim to identify new nutritional intervention opportunities and develop innovative product forms. Their largest innovation center is located in Utrecht Science Park, the Netherlands. It is a state-of-the-art center for the development of new nutritional product concepts for Early Life Nutrition and Advanced Medical Nutrition. They create products that provide clinically proven health benefits to vulnerable consumers – infants, toddlers, expecting mothers, the elderly and patients.
 

Contactinformatie

Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998

Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.

Uiteraard staat deze vacature open voor zowel mannen als vrouwen.

Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.