- Sumitomo Pharma (Boston, MA)
- …and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output + Contributes to interpretation of clinical trial ... currently available therapies and competitive clinical landscape + Experience in conducting global clinical trials in both early- and late-stage clinical … more
- Evident Scientific (Needham, MA)
- …leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards . The position serves as both a hands-on clinical ... submissions. ** Clinical Study Program Leadership** + Lead global clinical studies from concept to reporting;... clinical evidence synthesis. + Ensure alignment between clinical data , labeling, and regulatory claims. **Post-Market… more
- Sanofi Group (Cambridge, MA)
- …development, which require a scientifically inquisitive, energetic and proactive person. + Ensure Clinical Trial standards are maintained at the site and in ... & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives ... in clinical trial design (protocol and CRF development), execution ( data collection, analysis, and interpretation), and closeout (final reporting). + Oversee… more
- Takeda Pharmaceuticals (Boston, MA)
- …relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of ... of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations Program Lead(s): + Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local ... accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to… more
- Sumitomo Pharma (Boston, MA)
- …oncology patient care experience preferred. + Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...Medical Lead, perform regular medical review of individual subject data . + Collaborate with the Clinical Research… more
- Bristol Myers Squibb (Cambridge, MA)
- …2,100+ multi-site organization across 40+ countries; including Regional Clinical Operations, Global Trial Management, Global Data Management and Trial ... function, accountable to lead an integrated, end to end global clinical operations function accountable for acceleration...Maintains full GCP compliance and ensures the highest ethical standards of clinical trial and business conduct… more
- Parexel (Boston, MA)
- …+ When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical ... in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical … more
- Oracle (Boston, MA)
- …& Risk Awareness: Ensure that Clinical AI Agents meet healthcare industry standards for data privacy, transparency, and reliability. + Customer Engagement & ... Coordinate the training, tuning, and evaluation of models-ensuring alignment with clinical intent, performance benchmarks, and compliance standards . + Validation… more