Details

Open Date 08/28/2018

Requisition Number PRN18202B

Job Title Clinical Data Manager II

Working Title Research Data Coordinator

Job Grade E

FLSA Code Administrative

Patient Sensitive Job Code? No

Standard Hours per Week 20

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

VP Area President

Department 01167 - HCI Clinical Trials Operations

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 39300 to 47000

Close Date

Open Until Filled Yes

Job Summary

This position is primarily a study lead Clinical Data Manager. It supports multiple clinical study teams by reviewing and/or completing study related clinical data management deliverables. Frequently interacts with study team members to troubleshoot, manage, and develop study specific processes. Actively participates in the development of processes, and documents, that support the clinical data management team.

Responsibilities

1.Participate in the cross-functional project teams as the lead clinical data manager.

2.Provide input in the design of protocols, forms, and data collection processes.

3.Create and maintain the following study specific documents:

•Data Management Plans

•Edit specifications

•SAEReconciliation Guidelines

•Other plans and guidelines as required

4.Ensure documents are provided according to established timelines and SOPs.

5.Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.

6.Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.

7.Review and provide feedback on other study specific documents.

8.Manage all data management activities of a clinical trial in the maintenance phase of the project.

9.Provide project specific training on electronic data capture (EDC) and other data management systems to internal and external personnel.

Work Environment and Level of Frequency typically required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelor’s degree in the life sciences, pharmacy, nursing, a related subject, or equivalency. Requires two or more years of relevant clinical data management experience. Understanding of basic regulations involving clinical trials, clinical data management, and clinical data systems. Ability to perform all data management activities associated with a clinical trial with a high degree of quality. Possess all skills, knowledge and competencies required of theCDMI position.

Preferences

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.

To inquire about this posting, email: employment@utah.edu or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: oeo@umail.utah.edu .

The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.

This position may require the successful completion of a criminal background check and/or drug screen.