Senior Clinical Trial Manager
4 weeks ago
Beam Therapeutics Inc. is seeking a highly experienced Senior Clinical Trial Manager to lead the cross-functional team through all day-to-day activities within the clinical trial life cycle. The successful candidate will have a strong understanding of GCP/ICH Guidelines and a proven track record of managing clinical trials from start-up to close-out.
Key Responsibilities:- Manage all trial start-up, conduct, and close-out activities to industry and corporate standards.
- Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget.
- Contribute to the development of Informed Consent Forms and provide oversight and approval for all country and site level ICFs.
- Develop and maintain trial plans and site-facing documents.
- Support data management activities, including reviewing study-related support materials and participating in data cleaning activities.
- Monitor vendor metrics and performance, including KPIs and deviation reporting.
- Organize and participate in study-related meetings, including Investigator teleconferences and Clinical Study Team meetings.
- Develop and maintain the Trial Master File, ensuring it is final and audit-ready at the close of the study.
- Bachelor's Degree in a related field with 10+ years' experience in the biotech and/or pharmaceutical industries managing clinical trials.
- Phase I experience is preferred.
- Strong understanding of cross-functional clinical processes and GCP/ICH Guidelines.
- Exceptional organizational skills and ability to deal with competing priorities.
- Ability and willingness to travel up to 20% (domestic and international).
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Senior Clinical Trials Manager
4 weeks ago
Cambridge, Massachusetts, United States Merus Full timeSenior Clinical Trials ManagerMerus is seeking a highly skilled Senior Clinical Trials Manager to join our Clinical Operations team. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials, from planning to close-out. Your expertise in clinical trial management, combined with your passion for oncology,...
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Clinical Trial Coordinator
3 weeks ago
Cambridge, Massachusetts, United States IDRx Full timeAbout IDRxIDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. Our mission is to address the limitations of today's precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy.Job...
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Clinical Trials Director
3 weeks ago
Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full timeJob DescriptionWe are seeking a highly skilled Clinical Trials Director to lead the planning, implementation, and execution of global clinical trials. As a key member of our team, you will be responsible for managing clinical trials from start-up through close-out, ensuring that all components of the trial deliverables are executed to specified quality...
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Clinical Trial Director
3 weeks ago
Cambridge, Massachusetts, United States Garuda Therapeutics Full timeWe are seeking a Clinical Trial Manager to lead the planning, implementation, and execution of global clinical trials. Reporting to the Chief Medical Officer, you will bring collaboration, vendor management, and project management skills to this critical clinical operations role.The Clinical Trial Manager will be responsible for managing clinical trials from...
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Clinical Trial Oversight Director
4 weeks ago
Cambridge, Massachusetts, United States Alnylam Full timeJob Summary:The Associate Director, Clinical Trial Oversight will provide leadership and clinical operations experience to support Alnylam's oversight of CRO monitoring effectiveness. This position reports to the Director, Clinical Operations.Key Responsibilities: Develop and implement Alnylam's Clinical Trial Oversight strategy in alignment with ICH GCP E6...
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Clinical Trial Operations Lead
4 weeks ago
Cambridge, Massachusetts, United States Garuda Therapeutics Full timeWe are seeking a highly skilled Clinical Trial Manager to lead the planning, implementation, and execution of global clinical trials. Reporting directly to the Chief Medical Officer, you will bring strong collaboration, vendor management, and project management skills to this critical clinical operations role.The ideal candidate will have a strong background...
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Clinical Trial Operations Lead
4 weeks ago
Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full timeWe are seeking a seasoned Clinical Trial Manager to lead the planning, implementation, and execution of global clinical trials. This critical role will be responsible for managing clinical trials from start-up through close-out, ensuring all components deliver to specified quality standards.The ideal candidate will bring strong collaboration, vendor...
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Biostatistician - Clinical Trials
4 weeks ago
Cambridge, Massachusetts, United States Planet Pharma Full timeAbout the RoleWe are seeking a highly skilled Biostatistician to join our team at Planet Pharma. As a Biostatistician, you will play a critical role in the design, analysis, and interpretation of clinical trials data.Key ResponsibilitiesDesign and implement statistical analysis plans for clinical trialsDevelop and maintain SAS programs for data analysis and...
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Cambridge, Massachusetts, United States ICON Strategic Solutions Full timeJob Title: Sr. CRA**Job Summary:**We are seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to join our Clinical Operations team at ICON Strategic Solutions. The successful candidate will be responsible for providing leadership in the execution of clinical studies, ensuring high-quality data is delivered to sponsors on time,...
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Senior Director of Clinical Operations
4 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...
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Senior Clinical Data Manager
1 month ago
Cambridge, Massachusetts, United States Al Solutions Full timeMain Responsibilities:As a Senior Clinical Data Manager, you will be responsible for overseeing and managing data management activities to ensure high-quality data collection tools, database design, and oversight of data management activities for our sponsored clinical trials. You will contribute to the selection and development of data collection tools for...
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Clinical Trial Specialist
1 month ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob Title: Drug Safety SpecialistProclinical Staffing is seeking a skilled Drug Safety Specialist to join our team in Cambridge, MA.Job Summary:The successful candidate will support the Case Management and Vendor Oversight (CMVO) team by managing documentation, assisting with regulatory responses, and participating in quality control processes.Key...
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Senior Manager, Clinical Compliance
3 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob DetailsThe Role: The Senior Manager, Clinical Compliance will provide support and guidance to clinical trial teams on Clinical Compliance requirements and activities. The candidate will work to support trial teams across different stages of development and multiple therapeutic areas. The successful candidate will be skilled at both understanding and...
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Research Nurse
1 month ago
Cambridge, Massachusetts, United States Mass General Brigham Full timeJob Title: Research Nurse - Clinical TrialsMass General Brigham is seeking a highly skilled Research Nurse to join our team in Cambridge, Massachusetts.Job Summary:Under the general direction of the Principal Investigator, physician investigators, and the Clinical Research Program Manager, the Research Nurse will assist in the implementation of Cardiology...
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Senior Manager, Clinical Compliance Expert
3 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeClinical Compliance Leadership PositionThe Senior Manager, Clinical Compliance will provide critical support and guidance to clinical trial teams on Clinical Compliance requirements and activities.This role requires a collaborative partnership with cross-functional team members across the organization to ensure all trials are conducted in compliance with...
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Senior Director of Clinical Development
4 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing innovative therapeutics for serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and...
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Senior Manager, Clinical Researcher
4 weeks ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeKey ResponsibilitiesThe Senior Manager, Clinical Researcher will support the development of early and late phase Oncology Vaccine programs. This role will collaborate with the Study Physician to oversee clinical studies, review and interpret clinical trial data, and execute deliverables in collaboration with internal and external partners.The Clinical...
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Senior Clinical Document Manager
3 weeks ago
Cambridge, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Document Manager to join our team at Beacon Hill Life Sciences in Boston. This is a unique opportunity to work with a dynamic organization that values diversity and is committed to excellence in clinical document management.Job SummaryThe Senior Clinical Document Manager will be responsible for...
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Clinical Systems QA Specialist
4 weeks ago
Cambridge, Massachusetts, United States Poxy Clinical, LLC Full timeJob SummaryWe are seeking a highly skilled Clinical Systems QA Analyst to join our team at Poxy Clinical, LLC. As a key member of our team, you will be responsible for ensuring the quality and integrity of our clinical systems.Key ResponsibilitiesPerform quality reviews of User Requirements Specifications and Study ProtocolsCreate Test Scripts and other UAT...
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Senior Clinical Operations Manager
4 weeks ago
Cambridge, Massachusetts, United States Flagship Pioneering, Inc. Full timeAbout AlltrnaAlltrna is a pioneering company that is transforming the field of tRNA biology and therapeutics. As a leader in this space, we are committed to deciphering the complexities of tRNA and developing innovative treatments for thousands of diseases. Our platform incorporates AI/ML tools to learn the tRNA language and deliver programmable molecules...