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Senior Data Standards Expert (all genders)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role: We are seeking a Specialist Data Standard Expert - External Data to join our dynamic data standard team. In this role, you will utilize your extensive knowledge of External Data collection, ingestion, transformation, and storage to support our diverse clinical development portfolio. Working into standardization of the external data in SDTM compliant format and continue to build and support the external data SDTM library. As a key member of the team, you will be responsible for driving data standardization activities for a range of trials and data streams, from low to high complexity. You will serve as a subject matter expert on External Data domains such as non-CRF, Devices & Apps, Electronic Health Records (EHR), and Direct Data Capture. Operating in an agile and fast-paced environment, you will apply your creative problem-solving skills and stay updated on industry trends and innovative technologies related to External Data collection. Your primary responsibilities will include collaborating with cross-functional teams and external data providers to understand data requirements, analyzing data from external sources, leading the development of data standards in submission compliant format, and actively contributing to process improvement initiatives. This role can be based flexible in EMEA region.
Who you are:
- At minimum Bachelor's degree in Health Sciences, Clinical Data Management, or a related scientific field, along with
- A minimum of 5 years of relevant experience in the Pharmaceutical, CRO, or Biotech industry.
- Expertise in CDISC SDTM standards and submission requirements.
- Strong communication skills and experience working with external data providers and clinical data are essential.
- A solid understanding of drug development processes and industry standards is also required.
- Familiarity with data collection standards (CDASH, SDTM, HL7 FHIR, ODM)
- Experience with EHR/EMR, Digital Health technologies, and Real-World Data.
- Expertise in specialized data streams such as 'omics data, immunogenicity, flow cytometry, PK, and biomarkers.
- Proficiency in English is required.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.
North America Disclosure
If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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