Job Overview
Location
Boston
Job Type
Full-time
Category
Software Engineering
Date Posted
June 4, 2026
Full Job Description
đź“‹ Description
- • Lead and manage data management activities for assigned clinical trials across all phases (Phases 1-4) in a neuroscience-focused biopharmaceutical environment.
- • Collaborate with Clinical Sciences, Biostatistics, Clinical Operations, and other functions to design clinical trial databases, including CRF development, database validation, and data review tools compliant with ICH/GCP guidelines and regulatory requirements.
- • Oversee external data management vendors, monitoring key performance indicators, deliverables, timelines, and budgets; participate in vendor selection processes.
- • Optimize data collection processes by reviewing protocols for cross-trial consistency and identifying standardized case report form modules.
- • Support the creation of SDTM datasets, including oversight of external vendors responsible for data transformation and validation.
- • Maintain current knowledge of data management regulations, Health Authority requirements, and industry trends to inform strategic recommendations.
- • Propose, draft, and maintain Standard Operating Procedures (SOPs) and other departmental policies relevant to data management practices.
- • Participate in the selection and implementation of data management systems and technologies.
- • Perform hands-on database cleaning and generate patient-level listings as needed to ensure data integrity.
- • Apply expertise in safety laboratory data management and dictionary coding for adverse events and medications.
- • Contribute to the design and implementation of e-diary databases, particularly in CNS and pediatric rare disease areas.
- • Manage relationships with CROs and ensure alignment with company standards and project timelines.
- • Travel up to 10% domestically and internationally to support clinical trial activities and vendor meetings.
- • Adhere to company policies including the Code of Business Conduct and Ethics.
- • Act as a key member of the Clinical Development team, fostering collaboration across cross-functional departments.
- • Demonstrate science- and data-driven decision-making while applying creative and flexible problem-solving approaches.
- • Report to the Executive Director, Data Management and operate primarily from the Needham, MA office with a minimum of two onsite days per week.
🎯 Requirements
- • Bachelor’s degree in scientific, medical, computer science, or related field; Master’s degree preferred
- • Minimum of 5 years’ management-level experience in pharma or biotech data management
- • Strong experience in EDC database design, validation, and data review; familiarity with CDISC standards
- • Experience managing CROs and overseeing external data management vendors
- • Hands-on ability to perform database cleaning and generate patient-level listings
- • Experience in CNS, pediatric rare disease, or e-diary database design and implementation (preferred)
🏖️ Benefits
- • Base salary, target bonus, and stock options
- • Comprehensive medical, dental, and vision insurance
- • Short- and long-term disability, life insurance, and accidental death & dismemberment coverage
- • Employee Assistance Program and travel insurance
- • Retirement savings program with company matching contributions
- • Paid vacation, personal days, sick days, and end-of-year company shutdown
- • Tuition Assistance program for advanced degrees
- • Expanding Training, Learning & Development program
Skills & Technologies
About Xenon
Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.
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