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).
Top Skills
Clinical Data Management Solutions
R
SAS
SQL
Cytel Waltham, Massachusetts, USA Office
1050 Winter Street, Suite 2700, Waltham, MA, United States, 02451
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