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- 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.
- Lifting Not to exceed 50 lbs.
- Writing
- Sitting
- Standing
- Bending
- Visual acuity
- Color perception
- Depth perception
- Reading
- Field of vision/peripheral
- 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%.
- 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
- Project management skills
- 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.
- Team player with the ability to work well with technical and clinical teams.
- Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
Clinical Data Management Specialist - Boston, United States - Merit Medical Systems, Inc.
Description
Work Shift:
DAY
Work Schedule:
Why Merit?
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.ESSENTIAL FUNCTIONS PERFORMED
SUMMARY OF MINIMUM QUALIFICATIONS
PREFERRED QUALIFICATIONS
COMPETENCIES
COMMENTS
Infectious Control Risk Category I:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.
As an eligible Merit employee, you can expect the following:
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.