Senior Clinical Data Manager
2 maanden geleden
Short Intro and About the Job
Senior Clinical Data Manager
(Utrecht, full-time, hybrid)
As a Senior Clinical Data Manager specializing in Digital Health, you hold a central position within an international, multi-disciplinary study team. Your expertise in managing data from electronic Patient Reported Outcome (ePRO) and/or medical devices is critical. Your responsibilities encompass overseeing the clinical data management process in clinical trials, and you report directly to the Senior Team Leader of Clinical Data Management.
As the Senior Clinical Data Manager you will:
Design & validate electronic data capture instruments, for example electronic Patient Reported Outcomes (ePRO/eCOA) and eCRFs. Work with Medical Device and App vendors to set-up data collection for various digital tools and oversee the data transfer and data cleaning process. Create automated data entry checks and validation of the database outputs Lead and support innovation projects in the field of clinical data Act as a mentor for junior associates in the team Writing/ validation of the user acceptance testing (UAT) plan, Data Validation Plan (DVP) and Data Management Plan (DMP) Perform User Acceptance Testing (UAT)Perform query management and data validation Applying industry standard data models (CDISC CDASH & SDTM) Prepare the safety review, perform medical coding and Safety Adverse Events (SAE) reconciliation in cooperation with the Medical Monitor Prepare the Data Review Meeting (DRM) and database lock Monitor timelines and risks Collaborate with and provide support to (pre)clinical and life science researchers Oversight of CROs performing data management activities Setting up contracts with new CROs to perform data management activities
About You
We are looking for a Senior Clinical Data Manager specialized in Digital Health 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 Experience working with data from electronic Patient Reported Outcome and/or Medical Devices Knowledge of CDISC (CDASH and SDTM) Demonstrated ability to take initiative and work independently Has an interest in new tools and processes, willing to learn MedDRA, WHO Drug Programming experience (SAS/R/Python) Fluent in English (speaking and writing) A solid understanding of biomedical research, clinical trials, and Good Clinical Practice (GCP), drug/product development Pragmatic attitude and being adaptable to the changing needs of the business, being agile and flexible
About Us, We offer and What's next
Working here you’ll need to enjoy a fast-pace, complexity and it can get a little challenging. But it’s packed with opportunities. You’ll work with some of the best-known brands in the world, such as Evian, Nutricia, Activia and Nutrilon and we absolutely guarantee that you can just be yourself. Be innovative and entrepreneurial and the impact you could make might just amaze you. Join our movement for a healthier world. One Planet One Health BY YOU.
We are proud to be an equal employer. We are convinced our differences make the difference and that an inclusive working environment will drive our growth as a business, as teams and as individuals. We will therefore consider all applicants for employment* fostering an inclusive working culture that is accessible for all.
Did you know that as a B-Corp certified company, Danone Benelux meets the highest verified standards of social and environmental performance, transparency, and accountability?
We Offer
At Danone, we offer a complete package of benefits, with a competitive primary salary and yearly bonus, but also benefits like a premium free pension, 30 days annual leave and several discounts on a collective health insurance and even on some of our products. In the Netherlands we also offer a hybrid working environment which enables each team to meet our people's desire for flexibility. Across our 3 office hubs in Hoofddorp, Zoetermeer and Utrecht this helps us create better opportunities for connection & synergies across our entities, teams, functions and categories.
What’s next?
Hit the “apply now” button. After your application deadline first feedback will follow within 2 weeks. In case you are invited to the selection process you should expect to receive feedback 2 weeks after each step of the process
To comply with GDPR regulations, we cannot process your personal data without given consent. Therefore, we strongly recommend applying directly via our website.
Need more information? Please contact Valerija Usova, Talent Manager via all applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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