Clinical Data Manager
: Overview
RTI International's Technology Practice Area's Center for Clinical Research Technology is seeking a Clinical Data Manager to assist with the collection, management, and processing of data for a variety of multi-site research networks. The clinical data manager will work collaboratively as part of a multidisciplinary team to develop, test and manage research data and systems using a variety of off-the-shelf products and in-house software applications. This position will be key in supporting the lead data manager and/or performing all data management activities for federally funded clinical trials; monitoring and liaising with the clinical sites as required; and keeping the team informed of study issues and progress. This position is in a challenging, multi-disciplinary environment working with a dynamic group of professional, technical staff under the guidance of senior informatics staff.
Responsibilities- Working closely with sites to support data capture and cleaning, coordinating efficient corrections to the database, assisting with transfer of batch data and troubleshooting site challenges
- Defining necessary validations or reports to ensure quality and timeliness of data collection
- Monitoring study metrics and site performance using standard study management tools
- Developing data and workflow plans, training materials, technical guidance documentation, contributing to the development and implementation of SOPs.
- Developing test cases and performing user acceptance testing of EDC system
- Designing CRFs and eCRFs for data acquisition and data entry
Education and Experience:
- Bachelor's degree in health sciences, mathematics, computer science or related areas
- 3 years of related professional experience
- A combination of performance, education and prior work experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Required:
- Experience using electronic data capture systems or other commercial software tools and proven ability to learn and apply new software quickly as projects require
- Strong IT skills, including excellent knowledge of various software programs and packages including MS PowerPoint, MS Word, Excel
- Client-driven, excellent interpersonal skills and strong attention to detail
- Ability to work effectively both as part of a project team and independently is essential
- Excellent oral and written communication skills in English.
Preferred:
- Experience with SAS
- Proven experience providing project and data management support on FDA regulated studies, complex multi-site studies, data coordinating center projects or other studies
- Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs and client expectations
- Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
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