Clinical Quality Consultant

- Review eTMF for completed PK study to assure all relevant documents are included.
- Review study deviations to assure robust investigation performed with evaluation of impact on study.
- Evaluate CRO and study site personnel training.
- Review SIV and monitoring reports to determine issues and trends.
- Review study changes/ document updates (protocol, pharmacy manual, lab manual, etc) to determine potential IC update and reportability to IRB.
- Review IRB communications for adequacy and compliance.
- Review study drug preparation documents for consistency.
- Review SOPs utilized to manage study.
- Develop clinical governance procedures, as needed.
- Write clinical study oversight SOPs, as needed.

- 7+ years of pharmaceutical GCP experience (compliance preferable)
- Demonstrated technical knowledge, understanding and Experience in GCP
- Utilization of risk management skills
- Proven Experience successfully leading cross-functional global teams
- Demonstrated ability to influence effectively and implement change
- Excellent communication skills (oral, written, and presentational)
- Excellent planning and organizational skills
- Proven interpersonal skills
- Potential domestic travel to CRO and study site (estimated less than 10%) as needed to review information and discuss issues with clinical study staff

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