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eSource (EHR) Data Acquisition Expert (m/w/d) - Sponsor-dedicated (home-based, Germany)

extra holidays
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
Germany

Offer summary

Qualifications:

Bachelor's degree in Computer Science or equivalent, Minimum of 3 years' experience in clinical research data management, Experience with external data and clinical trials, Working knowledge of SDTM and GCP/ICH guidelines.

Key responsabilities:

  • Define, set-up and ingest External Data Streams
  • Collaborate with Data Managers and Study Responsible Physicians
IQVIA logo
IQVIA Large https://www.iqvia.com/
10001 Employees
About IQVIA
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
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Job description

  • eSOURCE Data Acquisition Expertise. The Data Acquisition Expert performs activities relating to the definition, set-up and ingestion of External Data Streams, and related documents and processes aligned with Clinical Trial Protocol defined requirements for data capture. Activities are conducted in close collaboration with Data Managers, Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
  • External data streams include but are not limited to typical and novel data collected through central labs and ECG, medical imaging, biomarker and genomics analysis, real world data sources, Electronic Health records, electronic patient reported outcomes, wearables and sensors and other digital data collection technologies.

  • Base Level:
  • Bachelor’s degree or equivalent, preferably in Computer Science.
  • Minimum of 3 years’ experience managing data in support of clinical research.
  • Experience working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
  • Experience working on clinical trials.
  • Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
  • Working knowledge of SDTM.
  • Working knowledge of GCP/ICH guidelines
  • Excellent written and verbal communication in English.
  • Demonstrated experience in working with external data providers within a clinical study setting.
  • Experience developing data transfer agreements.
  • Experience working with novel external data e.g., Real world data, digital health technologies, Electronic Health records (HL7, FIHR) or similar.

 

Advanced Level – see base level + relevant modifications below:

  • Minimum of 5 years’ experience managing data in support of clinical research.
  • Experience working with complex external data e.g., Biomarkers, Genomics, imaging or similar.
  • Demonstrated project management skills.
  • Experience working with novel external data e.g., Real world data, digital health technologies, Electronic Health records (HL7, FIHR) or similar.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Data ManagementProject ManagementClinical TrialsData AcquisitionData ExchangegRPCData ManagementElectronic Health Record ApplicationsICH GuidelinesDigital Health TechnologiesBiomarkersReal World DataGenomicsMedical Imaging

Other Skills

  • Teamwork
  • Collaboration
  • Communication
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