- 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 strong team orientated skills. + Ability to proactively lead internal meetings and with clients. + Ability to… 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), ... - Medical Support / Medical Monitoring for projects and studies contracted to Parexel - Deliver all medical support...task contracted) and according to the assigned role (Global Lead Physician GLP or Regional Lead Physician… 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
- 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 ... In close collaboration with Clinical Operations Program Lead (s): + Oversee the execution of studies ...Communicates study status, cost and issues to Clinical Operations Program Lead (s); serve as escalation… 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
- Parexel (Boston, MA)
- … development** PXL FSP is seeking a detail‑oriented and proactive **Feasibility Study Manager ** to support the delivery of high‑quality global feasibility ... fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. **Key… more
- Edwards Lifesciences (Boston, MA)
- …organizational, analytical and critical thinking skills + Extensive understanding of clinical studies procedures while defining team operating standards and ... Providing input on strategic direction on field monitoring of studies and data collection for clinical trials...for consistency with case report form, and determining if clinical trial/ study subject documentation is within parameters… 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
- 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 ... Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to… 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 ... Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to… more
- Beth Israel Lahey Health (Boston, MA)
- …job, you're making a difference in people's lives.** Under the direction of the Lead Cardiac Sonographer and Clinical Manager , the Cardiac Sonographer ... with reading physicians regarding echocardiogram findings. (essential) + Performs saline contrast studies and UEA studies as per protocol. (essential) +… more
- Sanofi Group (Waltham, MA)
- …Team. He/She will assume responsibility for methodological and statistical aspects of pre- clinical and/or non- clinical studies , with general direction from ... and assumptions of in vivo or in vitro preclinical studies and/or research, clinical and analytical (CMC)..., CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead… more
- Parexel (Boston, MA)
- …performance data and presenting as an integral member of the Clinical Study team for clinical development studies . The reviews include interpretation ... issues to be interpreted, reported and presented to the study teams. The Manager , Central Monitoring, will...Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis,… more
