Senior Clinical Data Manager-Elluminate Programming Job Cambridge area,Massachusetts USA,IT/Tech

Position: Senior Clinical Data Manager-Elluminate Programming a must
Job Description

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.

Responsibilities

Key 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.

Qualifications

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).