- BeOne Medicines (Emeryville, CA)
- …of clinical study processes + Able to independently lead large and/or complex global clinical studies + 5 or more years of progressive experience in ... timelines and budget + Leads all aspects of assigned clinical study (ies) + Leads global ...over the study life cycle + Ensures clinical studies at a project level are… more
- BeOne Medicines (Emeryville, CA)
- …provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional ... and budget + Acts as regional lead for multiple studies across an indication or across a program as...Clinical Study Report in collaboration with Global Clinical Study Manager… more
- BeOne Medicines (San Mateo, CA)
- …provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional ... Clinical Study Report in collaboration with Global Clinical Study Manager...and the quality of the work performed on assigned studies + Contributes to development, optimization and review of… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …(TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS team and serves as key ... leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and...studies and ensures scientific integrity and interpretation of study data of a clinical development program.… more
- Otsuka America Pharmaceutical Inc. (Olympia, WA)
- … Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, ... **Job Summary** The Senior Manager of Global Quality Management (GQM)...throughout the clinical development lifecycle. **Key Responsibilities** ** Clinical Study Support** + Serve as a… more
- BeOne Medicines (Emeryville, CA)
- …Head will lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated Franchise(s)- ... efficient study planning and execution of associated clinical programs/ studies + Conduct regular program review...and lead efforts to deepen scientific knowledge within the Clinical Operations' function + Champions a global … more
- Takeda Pharmaceuticals (Boston, MA)
- …innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical ... for and/or attending the inspections. + Represent the Lead Clinical Study Manager role in... studies or Phase 2 and 3 studies and global /international studies or… more
- Takeda Pharmaceuticals (Boston, MA)
- …innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical ... operational strategy and planning and oversee execution of clinical studies for an assigned clinical...related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management,… more
- Taiho Oncology (Princeton, NJ)
- …supervision, leads and manages complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ... we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other....trial milestones as well as overall day-to-day operations of clinical studies , ensuring study information… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …process improvement initiatives + Responsible for identification of innovative approaches to clinical study execution including global considerations and ... global execution of assigned large and/or complex clinical trials from study design, through execution,...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug… more
- Sanofi Group (Cambridge, MA)
- …is to: + Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs + Collaborate with other medical and ... medical input & support for all activities related to clinical studies conduct such as answers to...key medical and clinical questions with the Global feasibility manager to prepare and interpret… more
- ConvaTec (Lexington, MA)
- …the Eastern Time Zone **Key Responsibilities:** + Proactively manage assigned clinical studies . + Effectively manage clinical study delivery across the ... Clinical Study team during study start-up, routine monitoring, and closeout activities, demonstrating enthusiasm...team player. + Experience in pre-market (IDE) and post-market clinical studies . + Experience with Clinical… more
- ICON Clinical Research (Lenexa, KS)
- Clinical Study Manager -...and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to ... (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive... study management or director of operations, the study manager will be responsible for the… more
- Insight Global (Beachwood, OH)
- …Clinical Strategy & Protocol Development o Lead the development of IRB and clinical study protocols in alignment with company objectives. o Collaborate with ... surgeons and clinical advisors to design impactful studies that...- Clinical Execution & Oversight o Oversee clinical study activities including site selection, investigator… more
- ConvaTec (Lexington, MA)
- …guidelines, and regulations. + Working closely with the Global Head of Clinical Operations, develop study level operational strategy and clinical ... policies and SOPs. **Key Responsibilities:** + Working closely with Clinical Study Managers (CSMs) and Clinical...Clinical Research Organizations (CROs) and other vendors for clinical studies that are outsourced to third… more
- Dentsply Sirona (Charlotte, NC)
- …symbol XRAY. ** Clinical Research Manager AI** Do you want to work with clinical studies in a world leading dental company? This role will offer you a ... worldwide. This role will offer you great insight to clinical studies in a global ...clinical guidance on product design and validation, including study design for reader and standalone studies … more
- Cook Medical (West Lafayette, IN)
- …standards (eg, FDA, ISO14155, ICH-GCP, EU MDR) and country-specific regulatory requirements that impact clinical studies ; + Work with study teams to develop ... Template, Progress Report, Training Plan, Audit Plan, Monitoring Plan, Clinical Study Overview Presentation); + Participate in...lead CRA or 2 years of experience as Monitoring Manager ; * Sound knowledge of GCP and global… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …for global late phase studies * Coordinates review of interim/final clinical study reports.* Ensures effectiveness of site budget/contract processes + May ... Santa Monica as a Senior Clinical Trial Manager , specializing in Late Phase studies . **Essential...consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.* Develop and Maintains … more
- Taiho Oncology (Princeton, NJ)
- …+ Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies . + Updates internal study ... set-up, enrollment, site-related documentation, and inspection readiness. + Collaborates closely with study manager to align expectations and study … more
- ThermoFisher Scientific (Wilmington, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **CSM ( Clinical Study Manager ):** **OBJECTIVES:** **Lead or ... support study operational strategy and planning and oversee execution of select clinical studies ( global /regional and/or local country) for assigned … more