IT Technologist

**Careers that Change Lives
**GCH Bridge/ IMDRF Technical Lead Role**:
Technical lead for complaint handling/IMDRF bridge, which sends potential complaints from clinical trials to complaint handling system and sends adverse events and device deficiencies to IMDRF coding system.

There are several releases throughout the year

, which consist of adding new

clinical

studies

,

updates

to data for existing studies

and

o

ccasionally

,

updates to

the overall bridge logic

This role

is responsible for

ensuring the

accuracy and consistency of

the

changes

in each release.

**A Day in the Life**
- Responsibilities may include the following and other duties may be assigned.- Engages with business leaders to understand how strategies and data-driven changes can improve efficiencies and add value.
- Work with data sets to define use cases to improve products, processes and/or services.
- Collaborates with Business Relationship Manager (BRM), business stakeholders and IT Product Owners / Managers to develop business requirements for product or system changes.
- Drives business agenda during solution delivery process. Functional Skills: Ability to analyze data and trends in order to
- develop recommendations to solve business problems.
- Additional Skills: Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication.
- Technology: Understanding of systems, software and technological concepts, Familiarity with data analysis tools and data modeling methodologies.

**Summary of responsibilities**:

- Participate in requirements meetings, and provide input/feedback for requirements as needed, to ensure consistency with bridge logic and standards- . Create data mapping document for new studies and updates. Design the standard/custom profiles such that studies can reuse the mappings. Conduct impact assessment to e nsure new study design does not impact existing studies or bridge logic. Review document with developer to ensure
understanding Direct mapping developer as needed during development. Answer questions, make decisions about how to map data as needed. Ensure BA is aware of changes and how that impacts
the data that is sent via the bridge. Conduct code review for mapping development. Ensure standards are met. Review and update development standards as
needed
- Help write the test conditions to ensure all data is tested thoroughly, for new study as well as regression based on updates to existing functionality as needed.
- Review test scripts to ensure everything is being tested thoroughly. Help triage and/or resolve defects identified
during testing.
- Help identify/provide resolution for production issues escalated by support team. Point person for technical questions regarding
the bridge.
- Update bridge design documents, direct design discussions and development for any bridge logic changes As needed, c omplete development for bridge logic and/or study mapping - ( this is more of a good to have, not required )
. Collaborat e with clinical development partners in designing improved bridge interface model which can be leveraged
by both GCH bridge and safety reports. Identify areas of improvement for efficiency and standards for the bridge **Must Have: Minimum Requirements**
- Requires mastery of PL/SQL and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management.
- . Experience with data integrations and sending data from one system to
- another Experience with troubleshooting and problem solving in complex environments, multiple systems and multiple teams **Nice to Have**

**SPECIALIST CAREER STREAM**:
Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other
- lower level
- professionals.
- The majority of
- time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally
- acquired
- through advanced education.

**DIFFERENTIATING FACTORS**

**Autonomy**:
Recognized expert, managing large projects or processes.
- Exercises considerable latitude in
- determining
- deliverables of assignments, with limited oversight from manager.
- Coaches,
- reviews
- and delegates work
- to
- lower-level specialists.

**Organizational Impact**:
Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
- May manage large projects or processes that span outside of immediate job area.

**Innovation and Complexity**:
Problems and issues faced are difficult, moderately
- complex
- and undefined, and require detailed information gathering, analys