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.