Job Properties
  • Job Type
    Full-time Position
  • Category
    Research & Science
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Utrecht
    • Date Posted
      December 24,2021
    • Entrusting Package
    • JSS
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK

    Clinical Study Manager

    Bedrijfsomschrijving


    About the company

    Our client has worldwide R&D facilities and established a new research & innovation centre at the Utrecht Science Park.
    You will work in a life sciences innovation centre for the development of new product concepts for Baby Nutrition and Medical Nutrition. They create formulas that provide clinically substantiated health benefits to vulnerable consumers – infants, toddlers, elderly and patients. Capitalizing on their numerous international pre-clinical and clinical collaborations, they aim to identify new nutritional intervention opportunities and develop innovative product forms.


    Functieomschrijving

    Job Description

    Yacht Life Sciences has an opportunity for a Clinical Study Manager at International Food Innovation Company situated in Utrecht, the Netherlands.
    Are you passionate to make a health difference through specialized nutrition by providing clinical expertise in the start-up and operational management of clinical studies? Then you should let us know!

    Your mission:
    As clinical study manager you are responsible for the operational management of clinical research projects, including start-up, overall progress and reporting of the clinical studies, all in accordance with the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures.
    The CSM will work within the Clinical Research Operations group of the Specialized Nutrition Unit at this International Food Innovation Company. The CSM will play a crucial role in the start-up and operational management of clinical studies. He/she will take the lead in managing clinical studies or is a member of the study team. The CS Manager has clear leadership skills, and is able to act, decide and escalate autonomously and supports the Team Leader Clinical Studies in achieving the team deliverables.

    Other key responsibilities are:
    • Establishing a smooth and efficient cooperation within the multi-disciplinary project team, consisting of Clinical Study Researchers, Clinical Study Assistants (CSA’s), Data Management, Supplies, Quality and Science
    • Pro-actively looking for new implementations and changing the course when necessary
    • Ensure studies are set up and conducted in line with Good Clinical Practice (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)
    • Apply business strategy into the project
    • Day-to-day alignment with the team members

    Functie-eisen

    Job requirements

    We are looking for a Clinical Study Manager with:
    • A Master and/or PhD in life science or related scientific discipline
    • Extensive experience in (international) clinical research
    • Thorough knowledge of legislation and ICH-GCP guidelines
    • Ability to solve challenges with agile approaches
    • Project management and passionate leadership skills

    Arbeidsvoorwaarden


    Terms of employment

    This concerns a temporary secondment contract for 6 months (extension is possible), full-time is preferred (32 or 36 hours per week can be discussed). We will offer a salary in line with the seniority of the position, with a full-time salary between 5000 and 6000 euro gross per month (excluding 8% holiday allowance).

    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.


    Contactgegevens

    Anastassia Blechko
    Diemermere 25
    1112TC Diemen

    Email: anastassia.blechko@yacht.nl
     
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