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Principal Lead Data Manager

aplique agora
Localizações: Durham, Carolina do Norte Full time R1327370

Job description

Make an impact on the in-house clinical studies for a biopharma company. Join a sponsor-dedicated (FSP) team as a Principal Clinical Data Manager to be responsible for overseeing the start-up and execution of several clinical trials. Independently lead multiple complex studies within a development program. Perform various complex tasks to ensure complete, accurate, high quality, and regulatory compliant data supporting publications and regulatory submissions. Also, operate in a Project Management capacity for DM activities when collaborating with functional groups (data review, coding, etc.)

You will be responsible for:

  • Acting as the primary or lead data manager responsible for study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing including leading process improvements and enhancements, as needed.
  • Leading data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
  • Leading the development and maintenance of the data management plan (DMP).
  • Leading ongoing operational support for all activities, and at times leading specific projects or tasks, during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock and archiving activities. 
  • Accountable for all quality and compliance activities, including medical coding, report generation, drug supply, other database integrations, and external data activities.
  • Independently monitor activities and project status for successful project deliverables according to the timeline while participating in initiatives to streamline data management processes.

You will need to have:

  • Experience in clinical data management for 8+ years, with at least 4 years operating as a Lead Clinical Data Manager.
  • A Bachelor’s degree in a scientific discipline or equivalent.
  • Thorough knowledge of the clinical data management and clinical development process, including the regulatory submission process for the FDA, MHRA, PMDA, Health Canada, and EU regulatory agencies and knowledge of CDASH, MedDRA/WHO-DD dictionary coding and versioning, with exposure to digital technology, and data visualization technology.
  • Thorough knowledge and experience in clinical data operations and processes with skills supporting immediate step-in capability to start, maintain, and close-out studies, if needed.
  • Proficiency with technology associated with current and evolving data management practices, including electronic data capture and data aggregating.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

aplique agora

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