Senior Clinical Information Specialist - III Information Technology (IT) - Jersey City, NJ at Geebo

Senior Clinical Information Specialist - III

Job DescriptionJob title:
Senior Clinical Information Specialist - IIIJob location:
Remote Job duration:
6 Months Pay range:
$75 - $78/hr on W2
Job Description:
Responsible for collaborating with internal and external stakeholders to ensure that the software solution captures the necessary data points for data extraction, visualization, and real-time integration, implementing optimal eCOA processes, and building and improving relationships with eCOA/ePRO providers.
Regularly meets with internal and external teams to discuss open and emerging business issues related to eCOA/ePRO projects and systems, makes recommendations for improvements, and leads on their implementation.
Provide expert input, ensuring that clinical protocols are appropriately mapped to solutions efficiently, accurately and within project Product.
Identifies, develops, implements, and reviews effectiveness of current and new eCOA processes, including for new services, in collaboration with others.
Perform and support the UAT of the eCOA/ePRO configurations with necessary documentation.
Collaborates in the investigation of study issues found beyond the start-up phase of the study, especially the CAPA process with cross-functional teams.
Reviews and analyzes current metrics to identify trends and suggest process improvements.
Qualifications:
Electronic Clinical Outcome Assessment (eCOA) Solutions Lead Four-year college/university degree in computer science, engineering, life science, or healthcare related field with at least 5 years of experience working with clinical trials or in pharmaceutical industry.
Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models.
Five or more years demonstrated experience leading and implementing eCOA projects across multiple platforms.
(Experience in women health is a plus) Advanced computing skills, including experience with TRADOS or other translation management tools (CAT, or Computer Aided Translation tools) and eCOA vendor working files (e.
g.
, JSON, XML,) Knowledge of regulatory standards/guidance for eCOA/ePRO Demonstrated experience leading teams in a matrix working environment across projects.
#sczr2 Recommended Skills Biology Clinical Trials Clinical Works Data Collection Extensible Markup Language (Xml) Information Technology Estimated Salary: $20 to $28 per hour based on qualifications.

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