- 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
- Actalent (Cambridge, MA)
- As a Senior Manager Clinical Study Lead in Experimental Sciences, you will lead a cross-functional study team responsible for the delivery of ... clinical studies and research collaborations. You will serve as the... systems. Responsibilities + Lead the cross-functional study team for clinical study … 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
- 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
- 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
- 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
- Sumitomo Pharma (Boston, MA)
- …a pivotal role in supporting all aspects of central records for clinical studies across Phase 1-4. The Manager , Clinical Records Management, provides ... seeking a dynamic, highly motivated, and experienced individual for the position of ** Manager , Clinical Records Management.** The Manager , Clinical … 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
- Merck (Boston, MA)
- **Job Description** In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... and follow up of regulatory inspections. **Operational Quality Management:** + The Clinical Quality Operations Manager is accountable for overseeing the… 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
- 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
