- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **OBJECTIVES/PURPOSE:** The remote-based Senior Clinical Trial Associate (CTA) will independently perform tasks ... knowledge base. **CORE ELEMENTS RELATED TO THIS ROLE:** The remote-based Senior Clinical Trial Associate (CTA) will independently perform tasks related to… more
- Orchard Therapeutics (Boston, MA)
- …Specialty Pharmaceutical Company. Reporting to the Director of Clinical Operations, the Clinical Trial Associate (CTA) will be responsible for providing ... Location: Boston Reporting to: Senior Director, Clinical Operations Job Summary Orchard Therapeutics is a...project administrative and tracking support to the Clinical Study Managers for their assigned clinical … more
- Takeda Pharmaceuticals (Boston, MA)
- …serve the Clinical Sub-Team (CST)/Study Execution Team (SET) for end-to-end clinical trial delivery compliance and an aligned approach to inspection ... and empower you to shine? Join us as an Associate Director, GCP Excellence in Clinical Trials...Champion change and provide direct operational excellence strategies for clinical trial delivery projects and initiatives. **_A_**… more
- Takeda Pharmaceuticals (Boston, MA)
- …quality are considered. + Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively ... of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance...represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO,… more
- Philips (Cambridge, MA)
- …clinical sites, track enrollment, verify source data, and manage documentation within Clinical Trial Management Systems (CTMS) and eTMF. + Ensure adherence to ... ** Clinical Research Associate - Cambridge, MA**...Your skills include Electronic Data Capture (EDC) systems, eTMF, Clinical Trial Management Systems (CTMS), IRB processes,… more
- Takeda Pharmaceuticals (Lexington, MA)
- … Science Lead and TA Medical Teams. + Drive and deliver all aspects of clinical trial execution from study concept to final reporting **Research and Strategic ... application is true to the best of my knowledge. **Job Description** ** Associate Director, Clinical Research, Value & Evidence Generation, US Medical**… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science in our Gastrointestinal & Inflammation Therapeutic ... a vital contributor to our inspiring, bold mission **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global … more
- IQVIA (Boston, MA)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive,...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- Philips (Cambridge, MA)
- … research in a fast-paced, impactful environment? Join Philips CMO as a Senior Clinical Research Associate (CRA) and help shape the future of Emergency Care ... by ensuring excellence in clinical study execution. **Your role:** + In this role,... protocol requirements and regulatory expectations. Utilize and maintain trial management tools such as EDC, eTMF, and CTMS… more
- Takeda Pharmaceuticals (Boston, MA)
- …Breach review board meetings. + Lead complex quality investigations impacting the clinical trial delivery systems. + Provide Quality Leadership for Serious ... true to the best of my knowledge. **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … Director/Director). + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are necessary and ... products for the maintenance of everyday health We are seeking a Director, Global Clinical Development (GCD) who will be responsible for the design and oversight of … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … Director/Director). + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and ... **Job Description** Otsuka is seeking a Director, Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research… more
- Merck (Cambridge, MA)
- …+ Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and...drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. +… more
- Merck (Boston, MA)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Bristol Myers Squibb (Cambridge, MA)
- …the next wave of breakthrough therapies to reach patients faster through innovative clinical trial designs. **Responsibilities** + Lead a team of PhD level ... in neuroscience drug development and cutting-edge approaches for molecular/imaging/digital biomarkers and clinical trial design + Proficiency using R and 1+… more
- Takeda Pharmaceuticals (Boston, MA)
- …to cross-functional business partners about the need for additional data generation - clinical trial , real world evidence (RWE) such as registries and databases ... strategies for Health Technology Appraisal (HTA; including the EU Joint Clinical Assessment [JCA]) and payer assessments to optimize rapid, broad patient… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of those cancer patients and their families undergoing therapy in a clinical research trial . Strong interpersonal, organizational and communication skills are ... with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of… more
- Merck (Boston, MA)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... **Job Description** ** Associate ** **Director - Pharmacometrics,** **Quantitative Pharmacology and Pharmacometrics**...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions… more
- Takeda Pharmaceuticals (Boston, MA)
- …communications skills. + Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases. + Strong inter-personal skills. + ... order to bring life-changing therapies to patients worldwide. Join us as a Associate Director, Statistics in our Data and Quantitative Sciences (DQS) team. This team… more
- Bristol Myers Squibb (Cambridge, MA)
- …synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol ... coordination with clinical plans and marketing objectives. + Experience with clinical trial assays (CTA) in drug clinical trials in communicating between… more