Job Description Summary

As a Clinical Data Management Programmer, you will be responsible for supporting medical device clinical trials and research through developing and programming trials within an electronic data capture (EDC) system, as well as coordinating, facilitating, and participating in all data management activities from initiation of a study protocol, through final data archival. In this role, you will partner with Clinical Operations teams (Study Monitors, Statisticians, System Admin) and Clinical Project Managers to ensure strategic planning, resourcing, execution, and oversight of clinical trial data deliverables.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

  • Serve as the primary point of contact for assigned data management EDC programming and development activities for multiple clinical trials across a range of medical devices and program teams ensuring compliance with Good Clinical Practices, ISO 14155 and other applicable global regulations.
  • Works with Clinical Operations and Clinical Project Managers to ensure data management activities are conducted compliantly and according to project timelines.
  • Attends internal and external meetings as necessary to facilitate discussion and decisions for data management strategy pertaining to study, regulatory, or GCP specific requirements.
  • Develops and maintains study-specific Data Management Documents, such as DMPs, DVPs, CCGs and CRFs based on protocol and study requirements.
  • Builds clinical trial databases from data specifications, including edit checks, derivations, and Custom Functions.
  • Consults and collaborates with the Clinical Research Operations Team to review reporting needs and develops reporting mechanisms.
  • Works with SaaS vendors and the Clinical Business Process Manager to improve upon existing systems/functionality.
  • Keeps management informed on progress and other project related information, assist management in projecting resources, and perform administrative duties as requested.
  • Participates in team review and maintenance of QMS work instructions governing Clinical Data Management, always striving to identify and implement opportunities for improvement.

Required Qualifications

  • Bachelor’s degree, preferred in analytic discipline (Computer Science or Health related field) or high school diploma/GED with 6 years in Pharmaceutical/Biotechnology industry.
  • 1 year experience programming with C# and XML within Electronic Data Capture (EDC) systems (preferably Medidata Rave).
  • Demonstrate experience with requirement gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages.
  • Working knowledge of clinical research operations and documentation.

Desired Characteristics

  • Prior experience utilizing Medidata Rave EDC, Oracle Inform or Oracle Clinical One.
  • Prior experience designing in Architect.
  • Prior experience building dashboards using Business Intelligence tools (e.g., Business Objects, Power BI, Spotfire, Tableau).
  • Knowledge of Quality Management Systems (QMS) including experience with GDP and CAPA.
  • Demonstrate experience driving multiple projects and initiatives in a cross functional environment while leveraging key stakeholders and engaging end users.

We expect all employees to live and breathe our behaviors, to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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While GE Healthcare does not currently require U.S. employees to be vaccinated against COVID-19, some GE Healthcare customers have vaccination mandates that may apply to certain GE Healthcare employees.

Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

Relocation Assistance Provided: No

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Remote

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