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Manager, Data Management - External Data Services

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Job Details

The Manager of Data Management, External Data Services will be responsible for effectively supporting the Global Development Data Management organization by serving as the subject matter expert regarding the development of data transfer specifications for assigned studies. You will effectively lead and support data transfer specification standardization and serve as the primary point of contact for external data types including, but not limited to data from Biomarkers, Wearable Devices, IRT, Imaging and Electronic Clinical Outcomes Assessment (eCOA).

In this role, a typical day might include the following:

  • Provide subject matter expertise and assist in the development of the Data Transfer Specifications (DTS) for assigned studies.
  • Coordinate and train in the use of the DTS and other supplemental documents.
  • Provide visit mapping in the DTS including sampling timepoint.
  • Contribute to the development of DTS to align external data providers and research partners on the required structure for new data. This includes:
  • Responding to external data providers and internal partner queries to ensure data will be delivered in the correct format and structure.
  • Ensuring data structure is consistent across each data provider and align with appropriate data templates for various studies across Regeneron portfolio
  • Review and contribute to eCRF and EDC builds as it relates to external data acquisition requirements.
  • Contribute to improvement initiatives as it relates to external data.
  • Ensure study teams adhere to CDISC standards as it relates to external data.
  • Comply with all pertinent regulatory agency requirements (Understand clinical protocols and requirements for Biomarkers/Imaging/eCOA data, blinding and analysis expectations)
  • Serve as operational and technical liaison to external data providers and internal stakeholders

This role may be for you if:

  • Experience working with multiple data types/formats.
  • Experience with ingesting various data types and formats (Rave and non-Rave EDC, third-party, labs, imaging, and RWD, etc.).
  • Experience in managing clinical, biomarker data, eCOA and imaging data
  • Ability to collaborate and work effectively in a dynamic environment with cross-functional stakeholders such as scientists, operational leads, study physicians, data managers and external data providers to support data strategy
  • Strong organizational and communication skills in a matrix environment including strong attention to detail with a focus on delivering high quality results.
  • Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials
  • Strong analytical and problem-solving skills.
  • Expertise in biomarker data types and/or Imaging data for oncology and non-oncology studies is preferred
  • Strong attention to detail, timelines, and accuracy
  • Working knowledge of drug development, FDA & IHC/GCP regulations
  • Experience extracting data into SAS, CSV, and XML formats is required

To be considered you should have a  B.S degree – Major/ Minor (Biology, Biochemistry, or Business equivalent) with experience with programming and knowledge of data base structure. 5-8 years of data management experience in the pharmaceutical industry proven track record of managing external data and/or related vendors and processes

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!


Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

#GDRAJobs

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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