TrackWise Developer

TrackWise Digital Developer

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

Key Responsibilities

• 10+ years of Quality Management Implementation experience, with 4+ years of TrackWise Digital experience.
• 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 system, ensuring secure and reliable data exchange.
• Lead and support validation activities, including the development and execution of 1Q (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) scripts.
• Gather and analyze business requirements, translating them into technical solutions that align with compliance
• 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.

Qualifications:

• List required and preferred qualifications (up to 10). Include education, skills and experience.
• Minimum Bachelor's degree in Information Technology, Computer Science, Computer Engineering, Electrical Engineering
• Minimum 6 years experience in programming, application/ software development , or technical architecture
• Minimum 4 years leading technical teams responsible for providing solutions to business problems
• Strong communication and presentation skills
• Ability to use MS tools in support of Project Management, Presentation of Idea/Strategies, Data Manipulations
• Understand Computer System Validation/Verification and full (Agile and
• Waterfall) Software Life Cycle Management
• Experience in the Life Science Industry or similar industries is essential
• Experience in GP application development, maintenance.