Clinical Data Management Specialist

Merit Medical Systems, Inc.

23h•Onsite

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore. Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.

Requirements

Education and/or experience equivalent to a bachelor's degree in science, or related field.
Four (4) years of clinical data management experience.
Knowledge of clinical trials data processing concepts.
Demonstrated knowledge of data management processing systems.
Demonstrated experience in all areas of data management - database build, database maintenance and database lock.
Knowledge of ICH/GCP
Clinical data processing/research/query creation/report writing.
Demonstrated strong computer skills with computer skills with Microsoft Excel and Word, electronic data capture systems, internet research and other applicable software programs.
Ability to travel occasionally, up to 15%.

Nice To Haves

Experience in the medical device industry.
Demonstrated experience in all areas of data management - database build, database maintenance and database lock.
Familiar with statistics and data analytics using SAS, SPSS, Stata, R, or Python

Responsibilities

Performs clinical data and query review to ensure consistency, integrity and accuracy based on project specific guidelines.
Works closely with company Operating Procedures and ICH GCP and ensures correct processes are being followed.
Defines database requirements and data validations and performs/supports validation of data management systems.
Builds a database based on study specifications.
Participates in study team and all related meetings for assigned protocols by providing data management updates.
Participates in the development and maintenance of data management study documentation including the data management plan, reconciliation guidelines and eCRF specifications.
Assumes responsibility for all data management activities for assigned studies.
Produces and reviews metric reports for internal/external project teams.
Provides feedback for system/report improvement.
Performs other duties and tasks, as required.