- 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
- 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
- J&J Family of Companies (Boston, MA)
- Senior Clinical Data Analyst - 2406185694W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers ... https://www.jnj.com/. Biosense Webster, Inc is recruiting for a Senior Clinical Data Analyst, to be based at...leadership (including Programming and Biostatistics) to define and document data and process standards ; + Provide in-house… 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
- Actalent (Boston, MA)
- …of their drug candidates are invented and developed in house! Description: + Clinical Data Manager who will work collaboratively with vendor Project Managers ... and Clinical Data Managers to assure that ...according to company SOPs and in compliance with Company's data standards . + Serve as primary DM… more
- WTW (Boston, MA)
- …as a member of North America client team, you will collect and analyze data that informs strategic business decisions. The expectation will be to produce several ... role on individual projects will include elements such as data collection from vendors/ carriers, data validation,...concepts and principles and apply these skills in a global environment. Finally, you will interact with other members… more
- Sanofi Group (Cambridge, MA)
- …to drive and deliver on multiple operational tasks. CRDs lead the cross-functional Global Clinical Team to establish the development strategy and execute the ... + Understands and keeps up to date with the pre- clinical , translational and clinical data ...with internal and external stakeholders **Key responsibilities:** + Plans global clinical development strategy and generates the… 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
- 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
- ThermoFisher Scientific (Boston, MA)
- …that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD(R) clinical research services ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...letters in a timely manner using approved business writing standards . Escalates observed deficiencies and issues to clinical… 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
- J&J Family of Companies (Raynham, MA)
- …In close collaboration with Clinical Affairs Leaders, identifies and ensures global clinical strategies, resources and accountabilities are in place to ... are conducted in compliance to all applicable regulations and standards , are on-time and within budget. This leader leads... studies, for the supported franchises delivering high quality clinical data to support Regulatory, Market Access,… 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
- Merck (Boston, MA)
- …manner and in coordination with the study + CRM and CRA. + Interface with GCTO( Global Clinical Trial Operations) partners on clinical trial execution as ... This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company… 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
- 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
