Biotech External Data Acquisition Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Job Title: Biotech External Data Acquisition Specialist

A competitive salary band of $125,000-$170,000 per annum awaits the ideal candidate to lead our Clinical Data Management team in external data acquisition and integration.

About the Role

We are seeking a highly skilled Biotech External Data Acquisition Specialist to oversee the acquisition and integration of third-party data from laboratories, eCOA providers, technology vendors, etc. Your expertise will be instrumental in ensuring that the data collected is aligned with clinical trials' objectives and regulatory standards.

Responsibilities:
  • Develop and implement strategic insights into protocol development, focusing on external data collection and integration.
  • Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
  • Ensure that data transfer processes comply with CDASH and SDTM standards for efficient data analysis and reporting.
  • Collaborate with internal teams and external partners to ensure adherence to our requirements and timelines.
Requirements:
  • Bachelor's degree in science or a related field.
  • 3-5+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry.
  • Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer.
  • Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices.
  • Proficiency in CDISC (SDTM) standards and clinical data standards development.
  • Proven project management skills.
What We Offer:
  • A dynamic work environment with opportunities for growth and professional development.
  • The chance to make a significant impact in a fast-growing biotech company.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.


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