Senior Clinical Data Manager

1 week geleden

Utrecht, Utrecht, Nederland Danone Voltijd
Senior Clinical Data Manager

(Utrecht, full-time, hybrid)

Are you looking to leverage your expertise in data management in an intellectual, inspiring, and international setting? Do you thrive on demonstrating the business impact of conducting clinical studies, exploring new capabilities, and enhancing efficiency within data science?


As a Senior Clinical Data Manager, you will be tasked with establishing and managing data collection tools as per the Protocol, and overseeing the entire data management process until the database lock. You will be an integral part of a diverse international study team.

You will oversee the clinical data management process in clinical trials and report to the Senior Team Leader Clinical Data Management.


Your responsibilities will include:

  • Designing & validating electronic data capture instruments (e.g. electronic case report) with automated data entry checks and database output validation
  • Leading and supporting innovation projects in clinical data
  • Mentoring junior team members
  • Developing/validating the user acceptance testing (UAT) plan, Data Validation Plan (DVP), and Data Management Plan (DMP)
  • Conducting User Acceptance Testing (UAT)
  • Managing queries and data validation
  • Performing SDTM mapping of clinical data
  • Preparing safety reviews, executing medical coding, and reconciling Safety Adverse Events (SAE) in collaboration with the Medical Monitor
  • Organizing the Data Review Meeting (DRM) and finalizing database locks
  • Monitoring timelines and risks
  • Collaborating with and supporting (pre)clinical and life science researchers
  • Supervising CROs involved in data management activities
  • Establishing contracts with new CROs for data management operations
We are seeking a Senior Clinical Data Manager with the following skills and competencies:

  • Master's degree in Biomedical or Life Sciences
  • Minimum of 5 years of experience in clinical data management in pharmaceutical, nutritional, or academic research
  • Proficiency in CDISC (CDASH and SDTM)
  • Demonstrated ability to take initiative and work autonomously
  • Interest in adopting new tools and processes, with a willingness to learn
  • Experience with Electronic Data Capture (EDC), MedDRA, WHO Drug
  • Programming skills (SAS/R/Python)
  • Fluency in English (spoken and written)
  • Solid understanding of biomedical research, clinical trials, Good Clinical Practice (GCP), and drug/product development
  • Practical approach and flexibility to adapt to evolving business needs
Working in this role will involve a dynamic, sometimes challenging environment. However, it is brimming with opportunities.

You will collaborate with renowned brands like Evian, Nutricia, Activia, and Nutrilon, and rest assured, you can be your authentic self.

Embrace innovation and entrepreneurship, and you may be surprised by the impact you can create. Join us in our mission for a healthier world. One Planet One Health BY YOU.

We are proud to promote diversity in our workforce.

We firmly believe that our differences drive excellence, and an inclusive workplace will fuel our progress as a company and as individuals.

We welcome all applicants for employment* to foster an inclusive culture that is accessible to everyone.

Did you know that as a B-Corp certified company, Danone Benelux adheres to the highest verified standards of social and environmental performance, transparency, and accountability?

We Offer


At Danone, we provide a comprehensive benefits package, including a competitive salary and annual bonus, as well as perks like a premium-free pension, 30 days of annual leave, and various discounts on collective health insurance and select products.

In the Netherlands, we offer a hybrid work environment to accommodate our employees' desire for flexibility.

Across our 3 office locations in Hoofddorp, Zoetermeer, and Utrecht, this setup enables us to foster better connections and synergies within our teams, functions, and categories.

What's next?

Select the appropriate option to proceed. After submitting your application, expect initial feedback within 2 weeks. If you advance to the selection process, anticipate feedback 2 weeks after each stage.

To comply with GDPR regulations, we require your explicit consent to process your personal data. Therefore, we recommend applying directly through our website.

Need more details? Please reach out to Valerija Usova, Talent Manager. via

* All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

#LI-NL

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