Merit Medical Systems, Inc.
About the job
SUMMARY OF DUTIES*
Responsible for managing all aspects of clinical data management activities for multiple medical devices clinical trials. Activities may span across study start-up, conduct, and database lock activities.
Essential Functions Performed
- Develops Data Management documents such as CRF design for new forms, edit checks, CRF completion guidelines and Data Management Plan.
- Tests and validates study specific Electronic Data Capture System (EDC).
- Performs user acceptance testing oversight.
- Develops programs to check the integrity of the data, including range, error, and logic checks.
- Runs queries to verify data quality.
- Prepares reports on the quantity and quality of information from the data management system.
- Retrieves data and generates reports from the database as requested by senior staff.
- Assists with preparation of regulatory documents for submission to regulatory bodies.
- Performs SAE reconciliation.
- Ensures coding is kept current and accurate.
- Performs reconciliation of central lab data, when applicable.
- Monitors study status and ensures timelines are met to quality standards.
- Works in close collaboration with CRA before/during monitoring visits to resolve issues.
- Proactively identify and mitigate risks to assigned trial related to data management.
- Performs other duties and tasks, as required.
Summary Of Minimum Qualifications
- Education and/or experience are equivalent to a bachelor’s degree in a biological science or relevant discipline.
- Six years of clinical data management experience including Electronic Data Capture System.
- Coding experience with WHO Drug, ICD-9 and MedDRA.
- Knowledge of GCP, regulatory and ICH guidelines applicable to data management.
- Excellent written/verbal communication and organizational skills; ability to work as a team player.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Strong analytical skills.
- Ability to follow Clinical Data Management SOP’s.
- Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs.
- Strong organizational skills and the ability to be self-motivated and detailed oriented.
- Ability to travel to clinical sites, domestic and foreign, up to 25%.
- Database/coding/computer skills
- Report writing
- Analytical 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