The Senior Clinical Scientist will focus on the early and continuing scientific review of clinical data in various formats by applying the protocol and/or other applicable references along with oncology standards for the indication being studied to support overall data quality and consistency (clinical sense of the data), allowing the for insights to support a continuous risk management approach.
Precision medicine is revolutionizing the charge on cancerand we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials.
We offer an excellent compensation package, value our company culture and career advancement opportunities. This position is 100% remote!
Serves as the lead CSAI-OS representative on assigned project team(s)
Develops and maintains a good working relationship with internal and external project team members
Collaborates and is supported by CSAI-OS management as well as the Medical Monitors to support cross functional departmental communication to meet project results in compliance with GCP/ICH, the protocol, oncology standards and applicable Project Plans and SOPs
Serves as a valuable resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
Provides routine status updates on findings and advances issues as appropriate with project team and CSAI-OS Management
Identifies quality risks and issues and recommends corrective action plans as needed to address deficiencies in performance throughout the life of the project.
Bachelors degree or equivalent combination of education/experience in science or healthcare field with proficiency in medical terminology
At least six (6) years in clinical operations and/or, data management, safety or related subject area in either the CRO or pharmaceutical industry
Strong understanding of FDA & ICH/GCP regulations and guidelines
Ability to drive and travel up to 25% domestically and internationally including overnight stays
Experience as a Clinical Research Associate (CRA) preferred
Oncology therapeutic experience required with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.)
Experience in the review of data from oncology clinical trials with solid understanding of oncology standards (e.g., application of tumor response criteria, CTCAE criteria, etc.)
Knowledgeable about the operation of data monitoring committees, dose review committees, and independent response adjudication committees, etc.
Experience in phase I, II and III oncology (hematologic and/or non-hematologic tumors)
Medical related degree, RN, OCN, RPH, PharmD, etc.
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
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