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Clinical Programmer

Clinical Programmer

Katalyst HealthCares & Life SciencesCharlotte, NC
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Responsibilities :

  • Provide clinical programming expertise to support clinical trials, global filings, regulatory queries, data collection, and cleaning.
  • Provide input from statistical programming to support clinical trials, global filings, regulatory queries, labelling, and payer analyses, as well as scientific communications and publications.
  • Offer subject matter expertise to the design of data collection, data cleaning, SAP, and TFL mock shells.
  • Collaborate with cross-functional groups to ensure the successful execution of clinical trials.
  • Create, validate, or review SDTM, ADaM, and TFLs, mapping specifications, and variable definitions.
  • Review CSR analysis outputs and evaluate submission data packages.
  • Program, test, and document utility programs and tools per standard procedures.
  • Support daily operations, ensuring all assigned project tasks are completed accurately and on schedule.
  • Contribute to departmental process development and process improvement.
  • Patient Reported Outcomes (PROs).
  • Clinical Systems.
  • Data collection.
  • Data Cleaning.
  • Building a culture of care, engagement, and recognition with clear outcomes.

Requirements :

  • Bachelor's Degree in life science, computer science, engineering, business, or related discipline.
  • years of experience in clinical development.
  • Experience with SDTM and ADaM.
  • Familiarity with Patient Reported Outcomes (PROs) and common eCOA systems.
  • Knowledge of good clinical practices, data standards, and regulatory guidance related to PRO and eCOA.
  • Experience implementing clinical systems such as CTMS, EDC, ePRO or other related technology in the pharmaceutical / biotechnology industry.
  • Project management and technical expertise.
  • Excellent documentation and communication skills.
  • Excellent time management and organization skills.
  • Sound problem resolution, judgment, and decision-making abilities.
  • Good team player with a result-oriented attitude and can-do mentality.
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    Programmer • Charlotte, NC

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