- 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 ... preparing for and/or attending the inspections. + Represent the Lead Clinical Study Manager...study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3… more
- Astellas Pharma (Boston, MA)
- …regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to ... The CSM will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …4-days onsite in our Cambridge, MA office. Fully remote is not eligible._ The **Senior Clinical Study Lead ** (CSL) is expected to operate with high-degree of ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug...awareness of relevant industry trends + Ability to build, lead and develop productive study teams and… 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 ... In close collaboration with Clinical Operations Program Lead (s): + Oversee the execution of studies ...Communicates study status, cost and issues to Clinical Operations Program Lead (s); serve as escalation… more
- Actalent (Boston, MA)
- …project status, escalate issues, and troubleshoot routine inquiries with key stakeholders. + Lead the development of clinical study plans, including critical ... Title: Senior Study ManagerJob Description The Senior Study Manager will play a pivotal role...will play a pivotal role in managing and delivering clinical studies focused on ovarian cancer trials… more
- Takeda Pharmaceuticals (Boston, MA)
- …policies. + Lead ballparking, contracting and commercial management of complex clinical studies , understanding study requirements and translating into ... , Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing robust supplier contracts through commercial negotiations… more
- Philips (Cambridge, MA)
- …update the validation plan, develop validation testing protocols including phantom, animal and clinical studies and execute validation studies following Good ... ** Clinical Validation Lead (Cambridge, MA)** You... Research, MedTech or Healthcare. You have experience in pre- clinical and clinical testing, wrote study… more
- Bristol Myers Squibb (Cambridge, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, ... and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and compliance in all US Medical activities. + Drive and deliver all aspects of clinical study execution from study concept to final reporting, coordinate ... and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS)… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Medical SOPs and processes and propose process improvement. + Support implementation of all Clinical Study Manager and external resource activities to ensure ... **Job Description** The objective and purpose of the Senior Manager , US Medical Clinical Research, RPE position...laws. + Support Study Execution Team to lead Company Sponsored Studies forward to achieve… more
- Pfizer (Cambridge, MA)
- … Clinical Development & Operations (CD&O) organization, the Data Management Clinical Database Developer ( Manager ) is responsible for the design, development, ... standards supporting consistency in asset/submission data. The Data Management Clinical Database Developer ( Manager ) will be responsible...process and data operations required for the reporting of clinical trial data (eg data review, study … more
- Sanofi Group (Cambridge, MA)
- …select Exploratory Pharmacology studies ) and/or registries (eg: protocol, Key Results Memo, Clinical Study Report) + Support the TA CRDs with other ... Research Director (CRD) is noted as the primary clinical lead for complex priority projects, especially...expertise in clinical development and methodology of clinical studies + Demonstrated strong leadership, foster… more
- BeOne Medicines (Cambridge, MA)
- …Manager , Clinical Supply Chain in Cambridge, MA: **Job Duties:** + Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a ... proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s). + Develop supply strategies to maximize… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …timely manner to applicable study financial e-mail communications. + Assist Clinical Research Accounting Manager with month end reconciliation of Enterprise ... and refers only the most complex issues to the Clinical Research Accounting Manager . Provides leadership, coaching,...(ERP) data and Oncore Financials data. + Liaise with Clinical Research Financial Analyst and report on study… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Leadership:** **As a Statistician, the Senior Manager may have to:** + Lead one or more studies + Facilitate collaboration cross functionally and generally ... and mitigation **Skills and qualifications:** + Knowledge of drug development, clinical study design, trial simulations, analysis methodology and data… more
- IQVIA (Boston, MA)
- …clinical development scientists (CDS), if any and as assigned by the manager . + Lead one or more clinical study teams in the preparation of ... clinical program at regulatory meetings, as assigned by manager . **Essential Functions:** + Lead or support...subteam and oversee the design and execution of multiple clinical studies or clinical programs.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Inc. is seeking a Senior Manager , Programming with the following duties: Lead clinical studies , assigns and manages external full-service provider (FSP) ... FSPs and day-to-day prioritization; participate in the weekly Study Execution Team (SET) meetings; oversee external clinical...BIMO, P21 checks) and providing support for regulatory questions; Lead and organize study level programming and… more
- ICON Clinical Research (Boston, MA)
- …clinical development scientists (CDS), if any and as assigned by the manager . + Lead one or more clinical study teams in the preparation of ... subteam and oversee the design and execution of multiple clinical studies or clinical programs....other situations, as assigned by manager . + Lead the presentation of clinical trial related… more
- IQVIA (Boston, MA)
- …and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead , Customer Site Manager , and/or a leadership role in a specific CDM task ... budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management… more
- Takeda Pharmaceuticals (Boston, MA)
- … study protocols, statistical analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions. + Provide ... and collaborate in the design and conduct of observational studies to support clinical development of Takeda...+ Collaborate and partner internally with the GEO product lead and other functions to ensure GEO studies… more