Director - Oncology Research
Director - Oncology Research
Posted on :
29-04-2025
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1 Vacancy
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Job Description
Description
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking standing reading and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Job Summary
A senior member of the clinical trials leadership team that provides strategic direction develops and communicates vision for the department shares expertise across multiple discipline creates an environment of continuous improvement by defining business needs and driving transformational change sponsors and leads innovative projects and uses project management methodologies to position LCI for success helps develop and lead enterprise strategy through programmatic geographic technical and operational assessments and planning.
Essential Functions
- Demonstrates expert knowledge of Good Clinical Practices (GCP) International Conference on Harmonization (ICH) Guidelines as well as applicable rules/regulations pertaining to research. Knowledge of regulatory requirements of the Food and Drug Administration (FDA) Institutional Review Board (IRB) and Office of Human Subjects Protections (OHRP) pertaining to clinical research.
- Assists in developing the operational budget for the LCI Clinical Trials Department
- Provides strategic direction and oversight for clinical trial projects which are enterprisewide and assists with strategic planning for both the enterprisewide growth of clinical trials and associated operations.
- Performs metric analysis to ensure research workload for clinical trial operations meets the overall research team objectives.
- Responsible for comprehensive Time and Effort reporting requirements to Research Finance ensuring research time is allocated appropriately.
- Ensures all clinical trial operations are in compliance with ICH GCP and FDA requirements.
- Ensures appropriate documentation is maintained to meet applicable federal regulatory requirements as well as trial sponsor requirements.
- Ensures the department is prepared for sponsor and governmental audits and inspections.
- Provides updates to executive stakeholders on current/forecasted resource requirements accrual status financial performance investigator performance etc. through formal presentations and reports.
- Develops and monitors performance reports related to the trials portfolio (includes sponsor and CRO reports corporate financial performance corporate HR reports CTMSbased reports key performance indicators etc..
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking standing reading and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Education Experience and Certifications
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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