Job 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

1. Develops and oversees study operational plans.
2. Contributes in external vendor qualifications and selection related to clinical trials.
3. Manage CRO and other external vendors supporting clinical studies.
4. Participates in the design, planning and execution of multiple phases of clinical trials to GCP and IHC standards.
5. Oversees and ensures adherence to GCP and ICH guidelines, regulatory requirements, SOPs, and protocols; takes ownership for data completion and accuracy.
6. Contributes to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.
7. Contributes to study team for trial start-up, conduct and close-out activities according to industry and corporate standards.
8. Participate in study data review and assists with patient outcome narrative writing and other data review activities as assigned.
9. Oversees and participates in initiation, training and monitoring activities at clinical trial sites.
10. Contributes to creation of study documentation including clinical protocols, study tools, informed consent, investigator brochures, and clinical study reports.
11. May lead the work of Clinical Project Managers by training, mentoring, supervising work projects, etc.
12. Performs other duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. \xe2\x80\x93 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 discipline such as Biology, Chemistry, etc. or Life Science, etc.
• Six years of experience in the medical device, pharmaceutical drug development, biotech or CRO industries.
• Excellent knowledge of ICH/GCP.
• Experience managing outside vendors such as CRO\xe2\x80\x99s, consultants, and other subcontractors.
• Demonstrated effective verbal and written communication skills; fosters smooth flow of timely and relevant information.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
• Strong organizational skills and the ability to be self-motivated and be detailed oriented.
• Experience interfacing with multiple vendors/contractors.
• Proven ability to handle multiple projects and changing priorities.
• Must be results-driven and exhibit a sense of responsibility and outcome ownership.
• Ability to travel to clinical sites, domestic and foreign, up to 25%.

COMPETENCIES

• Clinical trials
• Management/external agency/company interaction
• Project task team participation
• Computer skills

COMMENTS

Infectious Control Risk Category III:

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 III states employment and procedures that do not 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 .

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

Merit Medical Systems