CRC Oncology is recruiting a bilingual (EN/CN) Clinical Scientist or Sr. Clinical Scientist, who will be responsible for the design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct. May lead or support trial level activities for one or more trials with the necessary supervision.
• Plan and execute clinical trial programs for assigned area of focus for registrational trials and/or non-registrational and/or research studies.
• Provide technical expertise to staff for the development of clinical trial documents and records (protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct.
• Oversee complex and significant studies.
• Represent the department at cross functional project teams and Business Unit level.
• Implement global study support strategies and initiatives.
• Regularly interact with executive management on work of area(s) that impacts larger organizational goals.
• Serve as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
• Collaborate and liaise with external partners (e.g., KOLs).
• Develop protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
• Conduct literature reviews.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present these at SIVs and investigator meetings.
• Review clinical narratives.
• Monitor clinical data for specific trends.
• Develop data review plan in collaboration with Data Management.
• Review data listings and tables to support data cleaning efforts.
• With supervision from the Medical Lead, participate in medical monitoring meetings with the CROs.
• Review protocol deviation classifications and coding.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission).
• Participate in vendor selection.
• Review site feasibility.
• Review key study documents.
• Develop DSMB/DMC study charters, prepare for and lead meetings for key study committees.
• Provide clinical /scientific advice to the study team and participating clinical sites.
• Review SAP and TLGs.
• Lead and develop clinical portion of advisory boards.
• Author and/or review abstracts, publications.
• Perform other duties, as necessary.
• Knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
• Ability to understand assigned protocol(s) and their requirements.
• Basic knowledge skills to support program-specific data review and trend identification.
• Intermediate medical writing skills and medical terminology.
• Basic planning/project management skills (develop short range plans that are realistic and effective).
• Detail-oriented with commitment to quality.
• Basic knowledge of disease area, compound, current clinical landscape.
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
• Intermediate critical thinking and problem-solving skills.
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools).
• Advanced Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
• Five years of pharmaceutical or biotech industry experience.
• Proficient in verbal and written English and Chinese.
• Clinical Research