- 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
- IQVIA (Boston, MA)
- …equipment provided._ **What You'll Do** + Lead data management for complex, global clinical trials from study setup to database lock. + Serve as the main ... titles may include _Clinical Data Manager , Senior Clinical Data Manager , Lead Data...Project Manager_ . + Proven success managing large global studies (1000+ patients). + Expertise with Medidata Rave, Oracle… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Lead , Early Clinical and...individual will also serve as Study Medical Manager (SMM) for selected clinical studies . ... accelerate progress. Join our state-of-the-art ECET department as a Clinical Lead , ECET and you'll drive the... Study preparation: + Design and conduct early clinical development studies including phase 2a within… 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
- Bristol Myers Squibb (Cambridge, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Development Lead sits within Clinical Development, which is ... 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 (Boston, MA)
- …years clinical study /project management. Experience must include early phase clinical studies /Phase 2 studies or later phase global programs. ... the Global Program Team (GPT) and partner with Global Clinical Lead to lead the...other vendors to ensure the effective execution of the clinical studies on time, with high quality… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …site, study , CRA, etc.) in a timely manner to the Monitoring Oversight Lead , Clinical Operations management, and Study Management as applicable * Ensure ... **Job** **Summary** The Manager , Clinical Operations works closely with...Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight… more
- Philips (Cambridge, MA)
- …team will lead a talented team in planning and executing clinical studies , ensuring regulatory compliance, process improvement, and impactful reporting to ... ** Clinical Operations Manager (Pittsburgh, PA local...oversight for the planning, execution, and resource allocation of clinical studies , ensuring data quality, adherence to… more
- Pfizer (Cambridge, MA)
- …informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical ... for programs within the Late-Stage Oncology portfolio. **KEY RESPONSIBILITIES** + Clinical development expert for assigned studies maintaining current scientific… more
- Oracle (Boston, MA)
- …across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical ... Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to… more
- Oracle (Boston, MA)
- …across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical ... Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Clinical FP&A, Manager in our Cambridge, MA office. At Takeda, we are transforming ... Organization. + Independently leads financial planning, analysis, and reporting for clinical trial costs. + Actively contributes to functional and project team… 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 ... ** Lead , Support and oversee the execution of clinical development and studies activities** + Collaborate...readiness and availability, and mandatory trainings linked to the clinical function + Lead the study… more
- Bristol Myers Squibb (Cambridge, MA)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... for a group of studies + Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists… more
- Parexel (Boston, MA)
- …Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) + ... + Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction, investigational product(s),… more
- Oracle (Boston, MA)
- …combined higher education and related work experience including: + Bachelor's degree in Nursing, Clinical Studies , Health Care, or related field + At least 1 ... plan, support the engagement management team in meeting deliverables and timelines, lead customer meetings to align clinical goals with technology, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Conduct data-driven feasibility assessments for Phase I - IV clinical studies , including protocol design optimization, country/site feasibility and ... effectiveness, and acceleration in Takeda's operational execution of its clinical research studies . + Ensure standards are...country footprint and proposed sites for participation in a clinical study . + Leverage leading industry tools… more
- Dana-Farber Cancer Institute (Boston, MA)
- …to the conduct of clinical trials and assist the disease group's Clinical Research Manager in their resolution + Manage the regulatory documentation ... The Clinical and Translational Investigation Program (CTIP) was established... research infrastructure. CTIP regulatory unit will support interventional studies to the IRB as well as assist with… more
- J&J Family of Companies (Boston, MA)
- …. Knowledge and experience in supporting device pre- and/or post-market clinical studies is preferred, including experience running investigational device ... treatment of calcified plaque. **Position Overview** The Therapy Development Manager (TDM) is responsible for being a clinical...**Requirements** . Bachelor's Degree in a scientific field of study or equivalent work experience . Minimum 6 years… more
- Edwards Lifesciences (Boston, MA)
- …small medical writing team to support clinical and regulatory submissions (eg, clinical study reports, clinical evaluation reports) and may indirectly ... expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of...and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and team… more