Clinical Quality Operations Manager, Oncology

Job Listing ID:

4496112

Job Title:

Clinical Quality Operations Manager, Oncology Application Deadline:

Open Until Filled

Job Location:

Salem

Date Posted:

05/21/2026

Hours Worked Per Week:

Not Provided Shift:

Not Provided Duration of Job:

Either Full or Part Time, more than 6 months You may contact this employer directly. (Obtain the contact information to print or add to your jobs.)

Job Summary:

Job Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Overarching Tasks:

It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement quality by design within clinical development programs, using a risk-based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Operational Quality Management:

The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of quality by design principles in assigned clinical trials. The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate. The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies. In partnership with the CQOL, the CQOM will develop skillsets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a profound knowledge of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials). The CQOM will build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with our research division QA and acting as the link between Clinical Development, study teams, global business functions and regional study management. The CQOM, in partnership with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle. The CQOM is accountable for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: Facilitating and monitoring CTT oversight of vendors Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies). Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizat...

Job Classification:

Natural Sciences Managers Access our statewide or regional occupation report for more information about wages, employment outlooks, skills, training programs, related occupations, and more. Compensation

Salary:

Not Provided Job Requirements

Experience Required:

 See Job Summary

Education Required:

None

Minimum Age:

N/A Gender:

N/A