- Parexel (Boston, MA)
- The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager , Study Managers, and Scientific ... from collection through testing and final sample disposition. This role requires clinical study , specimen management, and project management experience. As well… more
- 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 leading… more
- Novo Nordisk Inc. (Boston, MA)
- …products and services for their patients Maintain knowledge of the most recent clinical studies to inform customers and address questions, concerns, and ... CMCS I -Ecosystem I reports to the Ecosystem Business Manager . The CMCS I -Ecosystem I also must work...volume Utilize discretionary budget for maximum impact on sales Clinical Understanding Deep understanding of cardiometabolic disease state and… 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) has local responsibility for the delivery of the studies at allocated sites and is an active participant...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… more
- Parexel (Boston, MA)
- …for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international ... (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… 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)
- …champion, etc.). **Skills:** + Strong understanding of the different operational aspects of clinical study conducts in different regions across the world, which ... **Homebased US** As a Proposal Manager with Parexel you are in a client...(RFP) process + Receives and analyzes RFP documentation including study protocol or synopsis and ensures all appropriate Subject… more
- Parexel (Boston, MA)
- …champion, etc.). **Skills:** + Strong understanding of the different operational aspects of clinical study conducts in different regions across the world, which ... **US Homebased** A Contracts Manager with Parexel is a client facing role and requires consistent management of the contract management processes, development of… 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
- 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)
- …practice + Interact with clients and regulatory authorities + Review publications and clinical study reports + Travel to, attend, and actively contribute to ... discussing study results) + Additional responsibilities as defined by supervisor/ manager . **Skills:** + Good analytical skills + Good project management skills +… more
- Parexel (Boston, MA)
- …investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical ... /scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or… 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
- IQVIA (Boston, MA)
- …necessary equipment provided._ **What You'll Do** + Lead data management for complex, global clinical trials from study setup to database lock. + Serve as the ... + Your previous roles/job titles may include _Clinical Data Manager , Senior Clinical Data Manager ,...Project Manager_ . + Proven success managing large global studies (1000+ patients). + Expertise with Medidata Rave, Oracle… 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 Clinical ... for and/or attending the inspections. + Represent the Lead Clinical Study Manager role in...study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3… more
- Hologic (Marlborough, MA)
- Clinical Project Manager 4 United States...Lead planning and execution of complex clinical studies from protocol design to study closure, ... Skeletal Health Clinical Affairs team as a ** Clinical Project Manager ,** leading major US and...medical device industry. + Proven track record managing complex clinical studies and trials. + Experience in… more
- Philips (Cambridge, MA)
- …Care team will lead a talented team in planning and executing clinical studies , ensuring regulatory compliance, process improvement, and impactful reporting ... ** Clinical Operations Manager (Pittsburgh, PA local...oversight for the planning, execution, and resource allocation of clinical studies , ensuring data quality, adherence to… more
- Takeda Pharmaceuticals (Boston, MA)
- …innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical ... operational strategy and planning and oversee execution of clinical studies for an assigned clinical...clinical research organization, including 3 or more years clinical study management/oversight, including significant study… more
- Oracle (Boston, MA)
- …across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical ... Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to identify and mitigate… more
- Oracle (Boston, MA)
- …across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical ... Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to identify and mitigate… more
