- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage ... Responsibilities:** + **Inspection Readiness:** Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV)… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Cancer Institute's Breast Oncology Research Program is seeking a therapeutic clinical trial -focused patient navigator/educator to directly support patients ... into one focused on patients who are considering research participation in a clinical trial within the Breast Oncology Program. This position is also intended to… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …responsible for reviewing clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents to ... Analyst determines whether proposed clinical research studies are a Qualifying Clinical Trial as defined by the Medicare Clinical Trial Policy… more
- Norstella (Boston, MA)
- …services and Real World Data (RWD) offerings to support use cases across the clinical lifecycle including clinical trial planning, feasibility, and patient ... support activities **Qualifications:** * 5+ years experience in working in clinical trial relevant business either CRO, trial recruitment, consulting, or… more
- Takeda Pharmaceuticals (Boston, MA)
- …and perform trial simulations to provide innovative solutions and to optimize clinical trial designs. + Implement a quantitative decision making framework to ... skills. + Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases (Experience in Neuroscience preferred). +… more
- Medtronic (Boston, MA)
- …regulatory compliance guidelines for clinical trials. + Experience in clinical studies and/or trial site management/protocols. + Experience collaborating ... Travel up to 70%. In this exciting role as the **Principal Field Clinical Engineer (FCE)** for the Cardiac Ablation Solutions Operating Unit, you will be… more
- Takeda Pharmaceuticals (Boston, MA)
- …Third Party Data Acquisition based remotely reporting to the Senior Director, Clinical Trial Configuration. At Takeda, we are transforming the pharmaceutical ... + 10 or more years drug development experience. + Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports)… more
- Dana-Farber Cancer Institute (Boston, MA)
- …person responsible for the collaboration / navigation with the DFCI IRB contacts, clinical trial sponsors, DFCI designated Principal Investigator and the disease ... regulatory challenges related to the start-up, active, and closeout phases of the clinical trial life cycle and act as a leader in overseeing their resolution.… more
- Merck (Cambridge, MA)
- …+ Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. + Represent QP2 on cardiometabolic and… more
- Takeda Pharmaceuticals (Boston, MA)
- …apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies ... various other study documents and ensure they meet the study requirements; analyze clinical trial data by creating Tables, Listings and Figures using SAS as per… more