TrackWise Digital Solution Architect

TechDigital Group; Town of Florida (NY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

TechDigital Group in New York is seeking a TrackWise Digital Solution Architect to design, implement, and optimize TrackWise Digital solutions for life sciences, ensuring quality and regulatory compliance.

Lead configuration, deployment, validation, and integration efforts; develop technical documentation and coordinate with stakeholders across the organization.

Qualifications

• 12+ years of Quality Management Implementation experience, with 4+ years of TrackWise Digital experience.

Responsibilities

• Lead the configuration and deployment of TrackWise Digital applications, including permission sets, platform custom settings, remote site settings, and e-signature setup.
• Configure object search capabilities and manage record detail components, ensuring efficient data retrieval and system usability.
• Set up and maintain audit trails, multiple record linkages, and record access rules for secure and compliant operations.
• Design, implement, and optimize platform workflows, including multiple and parallel workflow models to accommodate complex business processes.
• Oversee workflow creation, testing, and deployment, ensuring seamless user experiences and regulatory adherence.
• Configure and maintain general Salesforce settings integral to the TrackWise Digital platform.
• Utilize TrackWise Digital utilities such as configuration deployment and report template builder to streamline system updates and reporting capabilities.
• Oversee user setup, permission group assignment, and access controls to ensure proper segregation of duties and compliance with internal policies.
• Design and manage data collection processes and EMDR (Electronic Medical Device Reporting) setup, including configuration for electronic submissions to regulatory agencies.
• Lead technical integration of TrackWise Digital with external systems, ensuring secure and reliable data exchange.
• Lead and support validation activities, including the development and execution of IQ, OQ, and PQ scripts.
• Gather and analyze business requirements, translating them into technical solutions that align with compliance and operational needs.
• Provide technical leadership and guidance to project teams, ensuring best practices in solution design and implementation.
• Develop and maintain comprehensive technical documentation, including configuration records, validation protocols, and user manuals.
• Communicate effectively with stakeholders at all levels, translating technical concepts into clear, actionable information.
• 12+ years of Quality Management Implementation experience, with 4+ years of TrackWise Digital experience.

Job description

The TrackWise Digital Solution Architect is a technical leadership role responsible for designing, implementing, and optimizing TrackWise Digital solutions within the Life Sciences industry.

Key Responsibilities

• Lead the configuration and deployment of TrackWise Digital applications, including permission sets, platform custom settings, remote site settings, and e-signature setup.
• Configure object search capabilities and manage record detail components, ensuring efficient data retrieval and system usability.
• Set up and maintain audit trails, multiple record linkages, and record access rules for secure and compliant operations.
• Design, implement, and optimize platform workflows, including multiple and parallel workflow models to accommodate complex business processes.
• Oversee workflow creation, testing, and deployment, ensuring seamless user experiences and regulatory adherence.
• Configure and maintain general Salesforce settings integral to the TrackWise Digital platform.
• Utilize TrackWise Digital utilities such as configuration deployment and report template builder to streamline system updates and reporting capabilities.
• Oversee user setup, permission group assignment, and access controls to ensure proper segregation of duties and compliance with internal policies.
• Design and manage data collection processes and EMDR (Electronic Medical Device Reporting) setup, including configuration for electronic submissions to regulatory agencies.
• Lead technical integration of TrackWise Digital with external systems, ensuring secure and reliable data exchange.
• Lead and support validation activities, including the development and execution of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) scripts.
• Gather and analyze business requirements, translating them into technical solutions that align with compliance and operational needs.
• Provide technical leadership and guidance to project teams, ensuring best practices in solution design and implementation.
• Develop and maintain comprehensive technical documentation, including configuration records, validation protocols, and user manuals.
• Communicate effectively with stakeholders at all levels, translating technical concepts into clear, actionable information.
• 12+ years of Quality Management Implementation experience, with 4+ years of TrackWise Digital experience.