Job Description Summary

The GEHC AVS segment, a fast-growing business in GE HealthCare, is the global leader in ultrasound medical devices and solutions. The portfolio spans the continuum of care to enable customers with ultrasound screening, diagnosis, treatment and monitoring of diseases. Our customers are seeking to improve efficiency in radiology and beyond and increase user confidence to provide better clinical outcomes continues to grow. Consequently, the need for AI, digital solutions, and automation, connecting devices and software in one seamless ecosystem continues to proliferate.

Caption Health is a part of GE HealthCare and focuses on developing clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans.

The Clinical Data Manager is responsible for multiple administrative tasks related to the organization of multiple internal and external clinical GEHC sponsored trials including our in-house clinical study, along with upkeep of clinical documentation as necessary.

Job Description

Essential Responsibilities:

• Serves as the primary point of contact for all data management activities for multiple clinical trials across a range of medical devices and program teams ensuring compliance with good clinical practice, ISO 14155, and other applicable regulations.
• Works with Clinical Operations and Clinical Research 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 decision 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 database from data specifications, including edit checks, derivations, and custom functions.
• Consults and collaborates with the Clinical Research Operations team to review reporting needs and develop reporting mechanisms. 
• Keeps management informed on progress and other project-related information.
• Assists management in projecting resources.
• Participates in team review and maintenance of QMS work instructions governing clinical data management, always striving to identify and implement opportunities for improvement.
• Travels to the Houston office when needed. Occasional travel to clinical trial sites to provide assistance.
• Performs administrative and other duties as assigned. 
   

Basic Qualifications:

• Bachelor's degree, preferred in analytic discipline (computer science or health-related field)
• 5-8 years of experience working with data management in the clinical trial industry (preferably medical device) that includes an understanding of regulations and laws regarding data privacy.
• At least 2 years of experience in at least one programming language (e.g. C#, Java, XML).
   

Preferred Qualifications:

• Working knowledge of clinical research operations and documentation.
• Experience working with electronic data capture (EDC) that includes building, validating, and decommissioning clinical databases.
• Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages.
• Experience utilizing Veeva CDMS or RedCap.
• Experience designing in Architect.
• Experience designing Custom Functions using C#.
• Experience building dashboards using Business Intelligence tools (e.g. Business Objects, Power BI, Spotfire, Tableau).
• Knowledge of Quality Management Systems (QMS).
• Proficiency in database design/management, programming languages, clinical data management tools, and MS Office.

Desired Characteristics:

• Well-organized and structured, high attention to detail. 
• Ability to work independently and systematically. 
• Highly detail-oriented.
• Exceptional interpersonal skills. 
• Proven communication skills, both written and verbal.
• Must be willing to travel as required (up to 10%). 
• Proven ability to drive multiple projects and initiatives in a cross-functional environment while leveraging key stakeholders and engaging end users. 

Eligibility Requirements:

• This position is based in the United States. Legal authorization to work in the U.S. is required. 
• Must be willing to travel as required.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position