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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 for assigned projects. The role focuses on scientific and indication-specific insights into data collection and data visualization outputs to support data cleaning as part of Precision’s cross-functional data review team. The Clinical Scientist serves as the subject matter expert in the application of clinical knowledge, guidelines, and standards of care to the review of clinical trial data.
Responsibilities include:
- Implementing Clinical Science Analytics & Insights (CSAI) services per study scope of work.
- Serving as a resource for project teams regarding scientific-related data capture, review, and cleaning.
- Supporting the development and implementation of the process flow for integrated, cross-functional data cleaning.
- Managing Medical Monitor review of subject data.
- Providing protocol review from a scientific operational perspective.
- Providing scientific, clinical input & support to Data Management in the development & revision of eCRF specifications, edit checks & completion guidelines.
- Conducting holistic &/or aggregate scientific, clinical sense data review.
The ideal candidate should possess:
- A Bachelor’s degree in science or a health-related discipline (or equivalent experience), plus proficiency in medical terminology.
- Minimum of 8 years of clinical research experience.
- Minimum of 1 year of leadership experience.
- Oncology therapeutic experience.
- Experience in trial phases I, II, and III.
- Experience with electronic data capture (EDC) systems and data visualization tools.
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
Precision for Medicine offers:
- Opportunity to work remotely
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.