Work Shift:
DAY

Work Schedule:

ESSENTIAL FUNCTIONS PERFORMED

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

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. -- local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS
• 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%.

PREFERRED QUALIFICATIONS
• 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

COMPETENCIES
• 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.

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. Risk category I states employment and procedures that will require exposure.

As an eligible Merit employee, you can expect the following:

* 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

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.