PS Clinical Data Manager II PS Clinical Data Manager II

1 month ago

Salt Lake, Utah, United States tapwage Full time
Department Vascular Surgery Development Job Summary

This position is primarily a study lead Clinical Data Manager.

The position will be assigned to the Salt Lake City VA project entitled, "Reducing Chronic Opioid Use Among veterans Undergoing Community Care Surgery Using a Transitional Pain Service".

The position will be assigned to the Salt Lake City VA. The position supports the study team 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.

This individual will be an experienced data manager. They will ensure consistent and accurate data availability to end-users, control privileges and permissions, and monitor database performance.

They will be responsible to devise methods and procedures for preparing data for statistical analysis and to conduct analysis as required.

Additionally, all database security will be maintained by this individual including familiarity with VA data security and privacy policies and adherence to these regulations in manipulating, preparing, disseminating, and analyzing study data.

Responsibilities

  • Participate in the cross-functional project teams as the lead clinical data manager.
  • Provide input in the design of protocols, forms, and data collection processes.

Create and maintain the following study specific documents:

  • Data Management Plans
  • Edit specifications
  • SAE Reconciliation Guidelines
  • Other plans and guidelines as required
  • Ensure documents are provided according to established timelines and SOPs.
  • Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
  • Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
  • Review and provide feedback on other study specific documents.
  • Manage all data management activities of a clinical trial in the maintenance phase of the project.
  • 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.

Problem Solving


Employees in this position are required to discuss questions and suggestion for improvements with the study team prior to implementing new or modified study specific processes.

The Clinical Data Manager II is expected to have a solid understanding of the regulatory framework as it relates to clinical research and data management, and be able to assess current and proposed processes for compliance with regulations and standards.

Comments


This position is intended to be focused on study level activities with oversight from the manager of clinical data management.

Employees are expected to be the independent representative of the clinical data management function on the cross functional study team.

Minimum Qualifications


Bachelor's degree in the life sciences, pharmacy, nursing, a related subject, or equivalency (one year of education can be substituted for two years of related work experience).

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 the CDM I position.

This position is patient-sensitive and must fulfill all associated requirements.

We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy.

Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Preferences Additional Information

The University is a participating employer with Utah Retirement Systems ("URS").

Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work).

Contact Human Resources at for information.

Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS' post-retirement rules and restrictions.

Please contact Utah Retirement Systems at or or University Human Resource Management at if you have questions regarding the post-retirement rules.

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


The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.

All qualified individuals are strongly encouraged to apply. Veterans' preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.


The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran's status.

The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106.

The requirement not to discriminate in education programs or activities extends to admission and employment.

Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.


To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action (OEO/AA).

More information, including the Director/Title IX Coordinator's office address, electronic mail address, and telephone number can be located at:

Online reports may be submitted at

This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses.

They also provide information about safety and security-related services offered by the University of Utah.

A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

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