- ACROBiosystems Inc. (Boston, MA)
- …validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies , commercial production, and companion diagnostics. We ... cross-functional collaboration and continuous learning. Job Summary The Regional Account Executive/ Manager (Junior to Senior level) role is responsible for… more
- Parexel (Boston, MA)
- …for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international ... **CRA and Sr CRA positions- Remote - Need for SE...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate ( Sr . CRA) is responsible for the site management, site monitoring and close-out of assigned ... Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) +… more
- Parexel (Boston, MA)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in ... for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Affairs to execute clinical strategy activities and oversee aspects of clinical studies in support of clinical evidence generation strategies across ... of Olympus's portfolio. Specifically, this individual will be responsible for writing clinical study protocols, case report forms, and study … 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 ... **Job Summary:** The Senior Medical Writer will research, create, and edit...skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study … 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 ... contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training… more
- Parexel (Boston, MA)
- …assigned project/ study . + Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), ... Supporting Activities - Medical Support / Medical Monitoring for projects and studies contracted to Parexel - Deliver all medical support required for successful… more
- Actalent (Cambridge, MA)
- As a Senior Manager Clinical Study Lead... study team responsible for the delivery of clinical studies and research collaborations. You will ... study systems. Responsibilities + Lead the cross-functional study team for clinical study ...Ensure accurate budget management and address scope changes for studies . + Escalate issues related to study … more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. **_Objective / Purpose:_** The Senior Manager , Clinical Partner Outsourcing (CPO) ensures seamless ... and policies. + Lead ballparking, contracting and commercial management of complex clinical studies , understanding study requirements and translating into… more
- IQVIA (Boston, MA)
- …Clinical Data Management role. + Your previous roles/job titles may include _Clinical Data Manager , Senior Clinical Data Manager , Lead Data Manager ... now and have your resume considered for Lead Data Manager opportunities across multiple teams - allowing us to...You'll Do** + Lead data management for complex, global clinical trials from study setup to database… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …and investigator registrations, clinical trials education, and committee management. The Clinical Trials Education Manager reports to the Director of ODQ. ... The Clinical Trials Education Manager is responsible for supervising and overseeing...Reporting metrics and statistics to the ODQ Director and senior DF/HCC leadership + Oversee the development, review, and… more
- Philips (Cambridge, MA)
- ** Clinical Study Manager , Computed Tomography (EST Time zone)** The Clinical Study Manager will be responsible for the execution and regulatory ... compliance of clinical studies for our Computed Tomography business....conducts trend analysis for risk mitigation, and delivers timely study updates and recommendations to leadership and senior… 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 ... + Independently leads financial planning, analysis, and reporting for clinical trial costs. + Actively contributes to functional and...+ Act as a trusted finance business partner to study team, and build an environment to both challenge… 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...documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Clinical Research Project Manager II manages day-to-day coordination and overall clinical trial activities for the Psychedelic-Assisted Therapy (PAT) ... therapies for individuals with advanced cancer and serious illness. The Clinical Research Project Manager II oversees trial startup coordination,… more
- Merck (Boston, MA)
- …and follow up of regulatory inspections. **Operational Quality Management:** + The Clinical Quality Operations Manager is accountable for overseeing the ... research division QA and acting as the link between Clinical Development, study teams, global business functions...of the quality management system are in place for studies conducted in partnership with non-commercial organizations (eg NGO,… more
- Bristol Myers Squibb (Cambridge, MA)
- …and execution of multiple clinical trials (eg significant experience as a senior clinical leader), and exhibits all of the following attributes: + Able ... 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good ... throughout the clinical development lifecycle. **Key Responsibilities** ** Clinical Study Support** + Serve as a...+ Monitor audit trends and escalate recurring issues to senior leadership. **Quality Systems & Compliance** + Support the… more
