10+ years of relevant experience supporting GxP projects.
Hands-on familiarity with the elluminate® platform and its modules or similar platforms.
Knowledge of Veeva preferred.
Strong verbal and written communication skills.
Ability to work independently and manage multiple tasks.
Bachelor's or Master's in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar discipline.
Experience in clinical systems configuration and clinical data platform delivery.
Proficient in SQL, Python, API development/integration, and ETL tools.
Strong knowledge of system validation frameworks and compliance standards.
Responsibilities
Build and maintain ETL pipelines and data quality/validation rules.
Configure elluminate® study modules and translate requirements into specifications.
Contribute to testing/validation efforts and manage audit trails.
Develop dashboards and monitor system performance and governance logs.
Support project governance and process standardization while ensuring regulatory compliance.
Manage Change Controls and system update-related documentation.
Interface effectively with system business owners and quality assurance teams.
Collaborate with the QA organization to execute computerized systems validation processes.
Benefits
Opportunities for professional development and continuous learning.
Work with cutting-edge technologies in a leading company.
Collaborative and supportive team environment.
Engagement in meaningful projects that impact patient outcomes.
Full Job Description
Roles & Responsibilities: -
Build and maintain ETL pipelines, metadata, mappings, and automated data quality/validation rules.
Configure elluminate® study modules (Mapper, Data Central, CTOA, Sample Management, Protocol Deviations) and translate requirements into specifications.
Contribute in testing/validation (IQ/OQ/PQ, UAT) efforts, manage audit trails, and resolve issues with vendors and study teams.
Develop dashboards/analytics across elluminate® modules and monitor system performance, integrations, and governance logs.
Support project governance, process standardization, template reuse, and continuous improvement across functions while ensuring GxP and regulatory compliance.
Support account management, routine user access reviews and release management activities for 25+ Blueprint Medicines SaaS computerized systems that fall under GxP regulations.
Manage/Assist in creating Change Controls and System update-related documentation.
Interface effectively with system business owners, quality (QA), and associated partners.
Manage onsite/offsite GxP resources to ensure efficient communication and execution.
Schedule maintenance and manage incidents with outside vendor-network.
Collaborate with the QA organization to develop and execute scalable, risk-based, computerized systems validation (CSV) processes and procedures.
rrange regular project governance meetings for assigned projects.
ctively participate in project meetings and walkthroughs.
Manage and oversee Account Management & Security processes for all BPMC regulated Systems.
Interface effectively with system business owners, quality and associated vendors.
Stay current with US and international regulations, industry standards, and emerging topics pertaining to GxP Computerized Systems, Computer Systems Validation and Data Integrity.
Prepare, review, and approve GxP Computerized Systems Validation life cycle and Change Control documents.
Qualifications:
10+ years of relevant experience supporting GxP projects.
Hands-on familiarity with the elluminate® platform and its modules (Mapper, Data Central, CTOA/Operational Analytics, Sample Management, Protocol Deviations, Clinical Analytics) or similar platforms.
Knowledge of Veeva preferred.
Strong verbal and written communication skills.
ble to work independently.
Bachelor's or Master's in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar.
Experience in clinical systems configuration, data engineering, clinical data platform delivery, or module implementations.
Proficiency in SQL, Python, API development/integration, ETL tools (Informatica/Talend/Fivetran), metadata management, and data lineage practices.
Strong knowledge of system validation frameworks and compliance (21 CFR Part 11, GxP, audit readiness).
Excellent ability to translate business requirements into technical configurations, collaborate with cross functional stakeholders, and deliver module-based solutions.
