- Insmed Incorporated (Boston, MA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along… more
- Merck (Boston, MA)
- …our existing and pipeline products to produce safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist, Associate ... Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical...Vocabulary Specialist may lead or participate in:** + Internal clinical data standards forums +… more
- Pfizer (Cambridge, MA)
- The Global Clinical Lead is a leadership role that represents clinical development on the Medicine Team as the single point of accountability for clinical ... heart failure and other cardiovascular indications. + Leads the Global Clinical Team towards the common goal...intended for external publication that are based on Pfizer-sponsored clinical trials + Interprets clinical data… more
- Editas Medicine (Cambridge, MA)
- …equitable future. Position Summary Reporting to the VP of Biometrics, the Director/Sr. Director, Clinical Data Management is responsible for all clinical ... leadership skills. Key Responsibilities: + As the Director/Sr. Director, Clinical Data Management, you will be responsible...Oracle Clinical Inform + Significant experience of clinical DM outsourcing with full service global … more
- Actalent (Cambridge, MA)
- …on-site 2-3 days a week** Primary Responsibilities * Independently lead / manage clinical data management activities * Manage the communications with Sponsor * ... setting * At least 8+ years as a lead Clinical Data Manager * Proficient in ...as well as general knowledge of industry practices and standards (CDASH, SDTM) * Knowledge and understanding of regulatory… more
- J&J Family of Companies (Cambridge, MA)
- Director, Global Development Data Science and Digital Health - 2406181828W **Description** Johnson and Johnson Innovative Medicine is recruiting for a Director, ... Global Development Data Science and Digital Health...performance for timely, quantifiable business impact and collaboration across Data Science, Operations, Clinical , and other partners… more
- Novo Nordisk (Lexington, MA)
- …journey? The Position This role will provide leadership and guidance to the Global Clinical Organization before, during and after inspections, working with ... vendor assessments and trying to impact external clinical requirements and sharing clinical Quality and GCP knowledge to the global organisation. We also… more
- GE HealthCare (Boston, MA)
- …and support in the assessment and promotion of compliance within all PDx departments including global clinical , non clinical and R&D. This role will be aware ... This role will have a focus on auditing and Global Compliance support to R&D & GCP activities but...clinical trial activities to ensure they meet GCP standards and contractual obligations. + Collaboration and Communication: QA… more
- Edwards Lifesciences (Boston, MA)
- …. **How you will make an impact:** + Design, create, validate, and modify clinical databases, and tools and programs for data validation checks, and ... in the design and delivery of moderately complex functional modules and provide data management expertise regarding clinical trials, protocols, and case report… more
- Bristol Myers Squibb (Cambridge, MA)
- …readout. + Has an active role in analysis and/or interpretation of clinical data and translation into scientific communication strategy, including publications, ... plan, including, clinical plans and labeling strategy; Appreciates translation of clinical data into claims and considerations for label development. +… more
- Sanofi Group (Cambridge, MA)
- …China and answers to questions from health authorities + Ensures clinical data meets all necessary regulatory standards + Participates in Advisory Committee ... investigator meetings + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety,...the study, compound, protocol + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs… more
- Sanofi Group (Cambridge, MA)
- …medical spokesperson for the studies and project . Ensures clinical data meets all necessary regulatory standards . Supports registrations, label submissions ... dissemination** . Ensures timely submission and dissemination of clinical data . Supports the planning of...the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with… more
- Sanofi Group (Cambridge, MA)
- …medical spokesperson for the studies and project + Ensures clinical data meets all necessary regulatory standards + Supports registrations, label submissions ... dissemination** + Ensures timely submission and dissemination of clinical data + Supports the planning of...the CRD must ensure that all activities of the Global Project Team (GPT) are conducted in compliance with… more
- ConvaTec (Lexington, MA)
- …of clinical studies across Convatec's Business Units. Reporting to Head Global Clinical Operations, this role is key representative for Study Management ... to project timelines and budget; report metrics to Head Global Clinical Operations as required. + Analyze...+ Work closely with other functional groups within Convatec's Clinical Operations team such as Data Analytics,… more
- Sanofi Group (Cambridge, MA)
- …problem solving skills . Understand and keep updated with the pre- clinical , clinical pharmacology and clinical data relevant to the molecule of ... one or more assets and document it in the clinical development plan in collaboration with the global...the review process, Advisory Committee preparation) . Contribute to data review, interpretation and publication of clinical … more
- Pfizer (Cambridge, MA)
- …a focus on innovative design, medical and scientific excellence, and the highest ethical standards . He or she will lead clinical development strategy and program ... deep medical and clinical knowledge to translate clinical research ideas into high-quality decision-making data ,...addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0%… more
- IQVIA (Boston, MA)
- …is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the ... **Elevate Your Career as a Clinical Trial Vendor Manager!** **About the Role:** Step...point for queries and ensuring vendors meet our high standards of quality and service. + **Risk Management Guru:**… more
- Astrix Technology (Boston, MA)
- Clinical Research Associate Clinical Data Management Boston, MA, US Pay Rate Low: 71.50 | Pay Rate High: 85.72 + Added - 13/05/2024 Apply for Job ** ... Monitoring and Site Management, Regulatory Compliance, Investigational Product (IP) and Clinical Supplies Oversight, Data Management, Safety Reporting, Close-Out… more
- Boehringer Ingelheim (Boston, MA)
- …acumen, Analytical skills, Learning and Adaptability * Demonstrated experience interpreting clinical data . * Displays AAI behaviors: Agility, Accountability, and ... and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering… more
- PCI Pharma Services (Bridgewater, MA)
- Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an ... better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of...network to pioneer and shape the future of PCI. ** Clinical Quality Inspector - First Shift** Perform and document… more
