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Precision for Medicine is seeking a Principal Clinical Scientist to work remotely. The Principal Clinical Scientist will manage the operational clinical science function from study start-up through database lock. They will focus on scientific and indication-specific insights into data collection and data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision’s cross-functional data review team. The role involves serving as the subject matter expert in the application of clinical knowledge, guidelines and standards of care to the review of clinical trial data.
The Principal Clinical Scientist will:
- Serve as the functional lead implementing CSAI services per study scope of work.
- Serve as a resource for project teams regarding scientific related data capture, review & cleaning.
- Support the development & implementation of process flow for integrated, cross-functional, data cleaning.
- Manage Medical Monitor review of subject data and provide protocol review.
- Provide indication-focused, scientific, clinical input & support to Data Management.
- Oversee & maintain CSAI project related plans, guidelines, & trackers.
- Support holistic & aggregate scientific, clinical sense data review.
Requirements for this role include:
- Bachelor’s degree in science or health-related discipline.
- Minimum of 8 years of clinical research experience.
- Minimum of 1 year of leadership experience.
- Oncology therapeutic experience.
- Experience with electronic data capture systems (EDC).
- Computer proficiency and professional use of the English language.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
Precision for Medicine offers:
- Remote work opportunity.
Precision Medicine Group
Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.