System Design Analyst I, Clinical Data Systems

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Develop and implement new clinical systems, system integrations, and necessary modifications to clinical systems such as EDC and IRT.

• Utilize project management tools to monitor study progress and organize tasks.

• Recognize issues that may impact timelines or quality and formulate solutions.

• Ensure that the requirements of the study protocol are incorporated into system designs.

• Employ common data standards to enhance system functionality, user experience, and data flow.

• Maintain consistency at the therapeutic-area and program levels.

• Collaborate with DSS and cross-functional team members to meet program and study goals.

• Align work products with upstream and downstream dependencies.

• Guarantee compliance with regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) Guidelines, Standard Operating Procedures (SOPs), and functional quality standards.

• Keep abreast of changing regulations, guidelines, and policies related to clinical development.

• Mentor and guide Data Science Associates.

• Engage in innovation and process enhancement initiatives.

⛳️ Requirements

• Bachelor’s degree in business, management information systems, computer science, life sciences, or a related field.

• Master’s degree is preferred.

• Over 3 years of clinical technology experience (e.g., EDC, IRT, ePRO), or more than 5 years in a similar technical or clinical development role.

• Familiarity with common industry design and development tools is advantageous.

• Proven understanding of the clinical trial process.

• Knowledge of CDASH and SDTM.

• Capability to influence others without direct authority.

• Strong communication skills.

• Strong analytical skills.

• Awareness of federal and relevant local regulations, GCPs, ICH Guidelines, and SOPs.

🏝️ Benefits

• Paid time off, which includes vacation, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Eligibility for remote work.

• Benefits as an equal opportunity employer and support for reasonable accommodations.