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 occasionally, updates to the overall bridge logic This role is responsible for ensuring the accuracy and consistency of the changes in each release.
Job Description
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.
A Day in the Life
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 ensure 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, complete development for bridge logic and/or study mapping–(this is more of a good to have, not required).
Collaborate with clinical development partnersin 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.
Requires 7+ years of experience with a bachelor’s degree or 5+ years of experience with an advanced degree or 12+ years of experience with a High School Diploma or equivalent.
Experience in the following applications is highly desired – Oracle Clinical, Medidata RAVE, Life Sciences Hub.
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, analysis and investigation.
Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
May negotiate with others to reach understanding or agreement, and influence decision-making.
Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.
Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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