PS Clinical Data Manager II
PS Clinical Data Manager II
Posted on :
19-04-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
19-04-2025
Job Description
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. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Huntsman Cancer Institute is committed to cancer prevention care and survivorship for all communities within the area we serve which includes Idaho Montana Nevada Utah and Wyoming with impact worldwide. Partnerships with individuals communities and many other entities are crucial to our work. Huntsman Cancer Institute values cancerrelated health equity and inclusion as integral to our guiding principle to serve our patients and their communities and our commitment to foster a culture of belonging for all within our organization. In your cover letter or during your interview process we invite you to share how your personal and professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research prevention clinical care community engagement/outreach training administration or other areas relevant to Huntsman Cancer Institutes mission and this position. Learn more here
Responsibilities
Essential Functions 1. Participate in the crossfunctional 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 SAE Reconciliation 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. 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. 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. 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
Bachelors 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 patientsensitive and must fulfill all associated requirements. We protect our patients coworkers and community by requiring all patientsensitive 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.
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. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Huntsman Cancer Institute is committed to cancer prevention care and survivorship for all communities within the area we serve which includes Idaho Montana Nevada Utah and Wyoming with impact worldwide. Partnerships with individuals communities and many other entities are crucial to our work. Huntsman Cancer Institute values cancerrelated health equity and inclusion as integral to our guiding principle to serve our patients and their communities and our commitment to foster a culture of belonging for all within our organization. In your cover letter or during your interview process we invite you to share how your personal and professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research prevention clinical care community engagement/outreach training administration or other areas relevant to Huntsman Cancer Institutes mission and this position. Learn more here
Responsibilities
Essential Functions 1. Participate in the crossfunctional 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 SAE Reconciliation 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. 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. 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. 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
Bachelors 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 patientsensitive and must fulfill all associated requirements. We protect our patients coworkers and community by requiring all patientsensitive 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.
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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