Skills: - An experienced and motivated individual with ~20 years of experience in the pharmaceutical industry with roles ranging from an Analytical Chemist; monitoring investigator sites as a CRA at a CRO; ensuring successful trial management/operations/inspection readiness as a country CRM (Clinical Research Manager); and designing, developing, authoring, and managing clinical trials including safety data/overall data review end-to-end as a Clinical Scientist- Experience as a Clinical Scientist for 10 years, specifically in early phase studies focusing on Oncology, Neurology, and Biomarker translational clinical trials- Extensive background in protocol design and authoring, informed consent authoring, result memos/CSRs, manuscript authoring/review, EDC creation, data entry/handling guideline authoring, data review procedures, training materials, vendor management, and ensuring end to end project management and compliance in clinical trials- Proficient in monitoring GCP compliance of clinical study sites, ensuring inspection readiness, and experience creating/responding to CAPAs- Background in country operations/management of late-stage clinical trials with tasks including site feasibility, validation, site selection, communication liaison, and overall project management of the study team to ensure end-to-end compliance and execution- Excellent presentation skills, detail oriented, proven to build strong working relationships internally and externally, as well as effective communication skills