- Parexel (Boston, MA)
- Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical ... Management** Study Team Support + Supports individual clinical study teams as required for all...Acquisition and Management + Works closely with data management lead to determine how sample and testing data will… 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
- Parexel (Boston, MA)
- …optimize trial performance. Additionally, the Manager will oversee multiple studies within a designated therapy area, lead process improvement initiatives, ... The Manager , Data Analysis, is responsible for overseeing centralized...for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance… more
- Parexel (Boston, MA)
- …management activities **CSR Narratives (as applicable)** + Performing medical review of Clinical study report narratives according to the client's guidelines and ... and sign off adverse events report for accuracy and clinical importance, relationship to the study drug...processing cycle + Provide input as necessary to Feasibility Studies , Data Monitoring Committees (DMCs), Clinical Endpoint… more
- Parexel (Boston, MA)
- …investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical ... Project Management** + Act in the capacity of project manager / lead for medical writing projects, which may...skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study … more
- Parexel (Boston, MA)
- …practice + Interact with clients and regulatory authorities + Review publications and clinical study reports + Travel to, attend, and actively contribute to ... statistical support, including trial design, protocol and CRF development on specific studies + Lead production and quality control of randomization, analysis… more
- Parexel (Boston, MA)
- …Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead ... providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to… more
- 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
- ConvaTec (Lexington, MA)
- …and Convatec's policies and SOPs. **Key Responsibilities:** + Working closely with Clinical Study Managers (CSMs) and Clinical Research Associates ... Clinical Research Organizations (CROs) and other vendors for clinical studies that are outsourced to third...lead CRA to ensure quality and completeness of study data. + Evaluate issues and suggest and implement… 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
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** Sr Manager , GCP Excellence in Clinical Trials **OBJECTIVES/PURPOSE** + Project manage and ... TMF process and inspection readiness strategies in collaboration with study execution teams and GCP Excellence in Clinical...readiness deliverables, and mitigation of inspection risks throughout the study lifecycle + Lead and guide … 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
- 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
- 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
- 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
- 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
- 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
