Clinical ProgrammerKatalyst HealthCares & Life Sciences • Charlotte, NC
Clinical Programmer
Katalyst HealthCares & Life Sciences • Charlotte, NC
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.
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 :
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