- Parexel (Boston, MA)
- …and regional study management. + Contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure ... regulations (eg FDA, EMA, NMPA, etc.). As such, the Clinical Operations Manager (COM) is responsible for...team (eg Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations , other GCTO functional areas, Pharmacovigilance… more
- Parexel (Boston, MA)
- …equivalent required; MBA or advanced degree is preferred. + Knowledge of clinical operations , protocols and recruitment strategies + Demonstrated patient centric ... considerations. + Demonstrated ability to work in a cross-functional environment with clinical operations , business technology, legal, finance, tax and other… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Operations Study Country Lead (COSCL) **Location:** US Remote **About the Job:** Are you ready to shape the future of medicine? ... helping our teams accelerate progress. We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support US clinical… 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. ... with our strategic partners and other vendors. + Represent Clinical Operations at the Global Program Team...other vendors to ensure the effective execution of the clinical studies on time, with high quality… more
- Sanofi Group (Cambridge, MA)
- …with the PDS, notably the engagement strategy, mindful of Regulatory Policy, Clinical Operations and payer value implications. Verticalization of local patient ... + Responsible for establishing, aligning and integrating strategic opportunities to accelerate clinical trials with Clinical Study Units (CSU) to… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Concept through Final Protocol + Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct ... Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality,...Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress +… more
- Sanofi Group (Cambridge, MA)
- …of digital biomarkers and Digital Health Technologies (DHTs) across Sanofi's clinical studies . Working closely with global and local study teams, you will ... (including studies ) in a combination of biomedical engineering, clinical research, digital biomarker operations , clinical operations , study … more
- Takeda Pharmaceuticals (Boston, MA)
- …data-driven feasibility assessments for Phase I - IV clinical studies , including protocol design optimization, country /site feasibility and selection, ... footprint and proposed sites for participation in a clinical study . + Leverage leading industry tools...sponsor or CRO. + 6+ years of experience in Clinical Operations , Data Analytics, global feasibility, and… more
- Lilly (Boston, MA)
- …and information to investigators and site personnel. + Serve as resource to clinical operations personnel / clinical research monitors, investigators and ... characteristics and effects of the molecule; consider all appropriate clinical strategies, development plans and study protocol...or have completed the comparable level of post-medical school clinical training relevant to the country of… more
- Takeda Pharmaceuticals (Boston, MA)
- …assigned studies . + Partner with Study Start up Managers, CROs, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and implement ... and support continuous improvement activities while developing TA-aligned strategies. + Partner with Study Startup, CRO and Clinical Operations teams as an… more
- East Boston Neighborhood Health Center (East Boston, MA)
- …Neighborhood Health Center! As one of the largest community health centers in the country , NeighborHealth is proud to serve the greater Boston area with a strong ... part of the essential support staff who keep our operations running smoothly - every role at NeighborHealth is...and ancillary support to the department mission through demonstrated clinical and academic competency in CT. Clinical … more
- Sanofi Group (Cambridge, MA)
- …to the submission of publications and presentations arising from Sanofi Specialty Care sponsored clinical studies , including Phase 3 and 4 studies , and ... up-to-date knowledge of statistical methods, especially those related to human clinical studies ; including composite endpoints, time-to-event and recurrent event… more
- Sumitomo Pharma (Boston, MA)
- …relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Sanofi Group (Cambridge, MA)
- …Generation Lead and other evidence generation-related functions for the subcutaneous formulation: Clinical Study Unit (CSU), Real World Evidence (RWE), Health ... Economics Outcomes Research (HEVA), Medical Operations and Effectiveness (MO&E) and country teams....support programs, CSRs, etc) + Oversee medical tactics and clinical study budgets planning and execution to… more
- East Boston Neighborhood Health Center (East Boston, MA)
- …Neighborhood Health Center! As one of the largest community health centers in the country , NeighborHealth is proud to serve the greater Boston area with a strong ... part of the essential support staff who keep our operations running smoothly - every role at NeighborHealth is...in Massachusetts and one of the largest in the country . From the nurses and physicians on the frontlines… more
- J&J Family of Companies (Cambridge, MA)
- …and data privacy standards. _Cross-functional & External Leadership_ + Collaborate with clinical operations to integrate digital health technologies into trial ... + Experience integrating digital solutions into patient recruitment, screening, and clinical trial operations . + Familiarity with data standards, privacy… more
- Sanofi Group (Cambridge, MA)
- …ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies .Ability to synthesize and critically analyze data ... Our department bridges the gap between technical development, manufacturing operations , and global regulatory authorities to ensure compliance while optimizing… more
- IQVIA (Boston, MA)
- To be eligible for this position, you must reside in the same country where the job is located. The General Manager for our Contract Sales practice will be primary ... by: + Manage expenses and drive profit growth. + Working with operations to support clients effectively, including recruiting, training, project management, etc. +… more
- East Boston Neighborhood Health Center (East Boston, MA)
- …Neighborhood Health Center! As one of the largest community health centers in the country , NeighborHealth is proud to serve the greater Boston area with a strong ... part of the essential support staff who keep our operations running smoothly - every role at NeighborHealth is...Building Position Summary: Medical Assistants are part of our clinical care team. Working in close partnership with a… more
