Danone Nutricia Research

Senior Clinical Study Manager - Utrecht

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Active since 06-02-2017 Job category Science, research & development
Location Utrecht Level Professional
Educational level Master / Post-Graduate / ... Employment type Temporary employment
Hours 32 - 40 Salary -
About Danone and our mission

Danone is a Fortune 500 company and one of the most successful nutrition companies in the world. Its mission is to bring health through nutrition to as many people as possible. It is this mission that guides our 1.850 “Danoners” in the Netherlands and more than 100.000 “Danoners” worldwide every day. We are convinced that Danone has “something special inside”. Our diverse business divisions and functions offer you a vast variety of career opportunities in a dynamic environment.

 

Nutricia Research is part of Danone. Our products are marketed under the brand names Nutricia, Milupa, SHS, Dumex and Blédina, amongst others. Capitalising on our numerous international preclinical and clinical collaborations, we aim to identify new nutritional intervention opportunities and develop innovative products.

Our centre for Specialised Nutrition located in the Utrecht Science Park, Netherlands, is a state of the art Life Science innovation centre for the development of new product concepts for Early Life Nutrition and Advanced Medical Nutrition. We create infant formulas and nutritional products that provide clinically substantiated health benefits to vulnerable patient populations.

 

Senior Clinical Studies Manager
Location: Utrecht

 

Your mission
For the Clinical Research Platform (Division Early Life Nutrition), we are looking for a senior clinical study manager. The senior CS Manager is responsible for the operational management of our international clinical studies. This includes preparation, initiation, conduct, progress reporting and closure of the studies according the Clinical Study Plan, ICH-GCP, applicable legislation and Standard Operating Procedures. You will be responsible for the operational feasibility of the protocol and translate the clinical study protocol to the clinical study plan. You will be the driving force behind a multi-disciplinary team. Your ability to lead the clinical study team and take responsibility for the quality, timeline and budget of the clinical study is central to the role. In addition, you will be responsible for the selection and management of external stakeholders, for example suppliers, sites and CRO’s. In this role you will report to the Clinical Studies Team Leader.

 

Your responsibilities

  • Ensure progress reporting (resources, budget, timelines)
  • Assess operational feasibility of study
  • Select countries, sites and investigators
  • Develop study documentation and create and maintain study files
  • Arrange EC/regulatory submissions and study registration
  • Set up and manage study budget, contracts and payments
  • Coordinate the selection and supervision of third parties
  • Perform and supervise site initiation, management and monitoring

Your Profile
As a minimum, you hold a Masters degree in life science or related scientific discipline. A PhD in Life Science or related discipline is preferred. You have at least 5 years of relevant experience in (international) clinical study management. You are flexible and have the ability to change focus easily between different subjects. You like to work very precise and you get energized by solving complex issues.

 

In addition, you will have the following competencies:

  • Extensive project management experience
  • Knowledge of project management techniques and tools
  • Proven experience in CRO/vendor management
  • • Proven experience in risk management
  • Familiarity with medical terminology
  • Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance
  • Learns fast, grasps the essence of our innovative ideas and can translate these into credible, scientific research, changing course when necessary.
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality
  • Ability to innovate and solve challenges with unique approaches
  • Excellent command of spoken and written English for writing papers, reports and delivering presentations
  • Ability to focus on the long term vision and be adaptable to the changing needs of the business
  • Desire to mentor others to strengthen their skill and abilities

You will also possess the following skills:

  • Critical thinking and problem solving
  • Planning and organizing
  • Decision-making
  • Initiative and self-motivation
  • Influencing and leading
  • Delegation
  • Team work
  • Negotiation
  • Conflict management

 

Are you the Senior Clinical Study Manager we are looking for?
If you have any question about the position, please contact Maaike Buijs (Corporate Recruiter) via + 31 (0)6 50295221. If you are interested, please apply via email to maaike.buijs@danone.com.

 

More information
This listing is a full-time job

Job category Science, research & development
Industry / Industries Food
Region Utrecht
Keywords MSc and PHD in life science + 5 years relevant experience in clinical study management. #Flexible #Leadership #Hands-on #Solution driven

Contact information

Name Maaike Buijs

Location

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