Responsible for managing all aspects of clinical data management activities for multiple clinical trials for medical devices. Activities may span across study start-up, conduct, and database lock activities.
ESSENTIAL FUNCTIONS PERFORMED
Development of Data Management documents (CRF design for new forms, edit checks, CRF completion guidelines, and Data Management Plan
Testing and validating study specific Electronic Data Capture System (EDC)
User acceptance testing oversight
Developing programs to check the integrity of the data, including range, error, and logic checks
Running queries to verify data quality on regular basis
Preparing reports on the quantity of data and quality in the data management system
Retrieving data and generating reports from the database as requested by senior staff
Assisting in preparation of regulatory documents for submission to regulatory bodies
Ensuring coding is kept current and accurate
Reconciliation of central lab data, when applicable
Monitor study status and ensure timelines will be met to quality
Work in close collaboration with CRA before/during monitoring visits to resolve issues
Proactively identify and mitigate risks to assigned trial related to data management
SUMMARY OF MINIMUM QUALIFICATIONS
A minimum of a bachelor’s degree/or experience equivalent to a bachelor’s degree in a biological science
Previous clinical data management experience
Demonstrated ability to follow Clinical Data Management SOPs
Coding experience with WHO Drug, ICD-9, MedDRA
Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management
Excellent written, verbal and organizational skills; work effectively as a team player
Self-motivated, self-directing, strong attention to detail and excellent time management skills.
Strong analytical skills.
Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
Employer will assist with relocation costs.
Internal Number: 730-16711
About Merit Medical Systems, INC
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies.
The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a ...direct sales force in Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V