The role involves programming for clinical trial data management, ensuring data accuracy, collaborating with teams, and mentoring junior staff.
We are seeking an experienced and skilled Clinical Programmer with a strong background within clinical programming. The ideal candidate will have 4-6 years of experience in clinical data programming, with a focus on clinical trial systems and data management solutions. This position requires a solid understanding of clinical trials, data integration, and programming techniques to support the creation, validation, and execution of clinical study data in a fast-paced environment.
ResponsibilitiesKey Responsibilities:
- Programming and Development: Write and maintain code for clinical trial data processes, including data extraction, transformation, and analysis using the multiple programming environment.
- Data Management and Quality: Ensure accurate and timely delivery of clinical trial data by performing data checks, validation, testing, and reconciliation in line with clinical trial timelines and regulatory requirements.
- Collaboration: Work closely with clinical data managers, statisticians, and other stakeholders to design and implement clinical data flow, ensuring compliance with all regulatory requirements.
- Troubleshooting and Issue Resolution: Identify, investigate, and resolve any issues that arise within the platform or clinical data programming processes.
- Documentation: Maintain comprehensive documentation of programming processes, code, and data management workflows for audit and regulatory purposes.
- Continuous Improvement: Contribute to the improvement of programming practices, tools, and templates to streamline clinical programming workflows and enhance efficiency.
- Training and Mentorship: Provide guidance and mentorship to junior programmers, ensuring adherence to best practices and facilitating knowledge sharing within the team.
- Experience: 4-6 years of experience in clinical programming and a background in Clinical Data Management
- Technical Skills:
- Proficient in clinical data programming languages (e.g., SAS, R, SQL, etc.).
- Expertise in clinical programming platforms, including experience with clinical data workflows, data integration, and programming solutions.
- Strong knowledge of clinical trial data structures, data standards (e.g., CDISC, SDTM), and regulatory requirements (e.g., FDA, EMEA).
- Problem-Solving: Excellent troubleshooting and problem-solving skills with the ability to work under pressure to meet deadlines.
- Communication: Strong communication skills with the ability to collaborate effectively with cross-functional teams and communicate technical concepts to non-technical stakeholders.
- Education: Bachelor’s degree or higher in Computer Science, Life Sciences, Engineering, or related field (or equivalent work experience).
Cytel Waltham, Massachusetts, USA Office
1050 Winter Street, Suite 2700, Waltham, MA, United States, 02451
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