Clinical Programmer
Clinical Programmer
Posted on :
11-04-2025
Employer Active
1 Vacancy
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Job Description
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 crossfunctional groups to ensure the successful 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:
- Bachelors Degree in life science computer science engineering business or related discipline.
- 4 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.
- Attention to detail.
- Excellent documentation and communication skills.
- Excellent time management and organization skills.
- Sound problem resolution judgment and decisionmaking abilities.
- Good team player with a resultoriented attitude and cando mentality.
- Maintaining an inclusive environment through persistent selfreflection.
Employment Type
Full Time
Key Skills
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