We anticipate the application window for this opening will close on - 15 Nov 2024

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Position can be remote in the United States and will be working central or eastern time zone hours.

As a member of Medtronic Clinical and Regulatory Solutions (MCRS), Data & Safety Solutions (DSS), Solutions Design & Optimization (SDO) team, this position is responsible for applying design and development expertise and understanding of clinical processes to the design and development of reports and custom components as needed to support clinical trials.

As a member of Medtronic Clinical and Regulatory Solutions (MCRS), Data & Safety Solutions (DSS), Solutions Design & Optimization (SDO) team, this position is responsible for applying design and development expertise and understanding of clinical processes to the design and development of reports and custom components as needed to support clinical trials.

This position:

• Supports or executes design, development and maintenance activities related to clinical study reports and/or dashboards, interfaces and other transfer processes that exchange relevant data across clinical systems, and other components

• Interacts with internal DSS colleagues (Clinical Data Specialists, Statistical Programmers, and Safety Specialists), MCRS partners and possibly business partners including clinical study teams, Global IT, business strategists, and statisticians

• May support and/or work with additional project teams, disciplines, or functions within Medtronic

POSITION RESPONSIBILITIES:

• Plan, analyze, design, develop, test, deploy and/or support Clinical Reports, Clinical Data Transfer/Interfaces or other components related to the clinical studies.

• Understand and utilize industry standards to contribute to defining and implementing reporting standards for the development team

• Support other Clinical Business Intelligence Specialists on planning, designing, and implementing Clinical Reports and Dashboards, Clinical Data Transfers/ Interfaces, or other components.

• Mentor junior team members

• Understand the design of business unit and enterprise system datasets/databases and contribute to testing and/or supporting them

• Partner as clinical technical specialists in the planning, designing, and implementing of clinical applications

• May provide technical consultation on and task direction for vendors

• Stay current on technologies, methods, standards, and best practices as well as trends and direction of the clinical data management industry

• Review and acknowledge all Standard Operating Procedures and other quality requirements assigned to the job role.

Must Have:

• Bachelor’s degree plus 4+ years of development experience (2+ year with an advanced degree)

Nice to Have:

• Bachelor’s degree in Computer Science, IT, or Science

• Clinical database knowledge: advanced level of proficiency with relational databases and clinical operations data. Detail-oriented view of reporting processes, tools and procedures.

• Knowledge of systems development life cycle and relational databases

• Knowledge of documentation and validation practices as applicable to the development of software components in a clinical research or similarly regulated environment

• Experience in developing reporting solutions in support to business processes in a clinical research or similarly regulated environment

• Knowledge of ICH/GCP/FDA regulations and guidelines as they pertain to clinical systems including 21 CRF Part 11

• Familiarity with SQL code development (intermediate to advanced database and query development)

• Familiarity the Microsoft SQL Server suite, primarily MS SQL Reporting Services (intermediate to advanced solutions and report development)

• Familiarity with Microsoft Power BI (basic to intermediate dashboard development)

• SQL Server, Oracle Clinical, Siebel CTMS, Clinical Development Analytics and/or other SQL-based Databases and Clinical applications

• Familiarity with project management practices (as needed to be able to co-lead and co- administer a project)

Key business Competencies:

• Adaptability

• Customer Focus

• Drive for Results

• Cross-Cultural Respect