Merit Medical Systems, Inc.
About the job
SUMMARY OF DUTIES*
Maintains clinical databases, creates queries and reports, and analyzes data to comply with regulatory reporting requirements and support improvements in clinical effectiveness.
Essential Functions Performed
- Performs clinical data and query review.
- Creates queries to determine the clinical effectiveness and ensures compliance with regulatory requirements.
- Performs/supports validation of data management system.
- Performs research for data collection and protocol topics.
- Assists with the creation and maintenance of documentation for clinical studies, following CRF guidelines and other guidelines.
- Participates in the development of a data management plan, reconciliation guidelines, and report specifications.
- Produces and reviews metric reports for internal/external project teams.
- Provides feedback for system/report improvement.
- Performs other duties and tasks, as required.
Summary Of Minimum Qualifications
- Education and/or experience equivalent to a bachelor’s degree in computer science, business or related field and four years of clinical data analytics experience.
- Knowledge of clinical trials data processing concepts.
- Demonstrated knowledge of data management processing systems.
- Project management experience.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Excellent written/verbal communication skills.
- Excellent organizational skills.
- Strong analytical and problem-solving skills.
- Strong interpersonal skills.
- Knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA etc.)
- Team player with the ability to work well with the technical and clinical team.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
- Ability to travel occasionally, up to 15%.
- Experience in the medical device industry.
- Thorough knowledge of RDBMS and relational database models
- Experience using Structured Query Language (SQL)
- Strong skills using Microsoft Excel, Pivot Tables, Power Query, and VBA
- Familiar with statistics and data analytics using SAS, SPSS, Stata, R, or Python
- Clinical data processing/research/query creation/report writing
- Project management skills
- Computer skills
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. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at www.youtube.com/meritmedical to see the video titled “Great people, Great products, Great Company”. Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.
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. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. 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