- 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
- Merck (Boston, MA)
- …ensuring successful delivery of projects on time, within budget, and meeting quality standards . You will play a critical role in driving the strategic direction of ... + Bachelor's Degree with at least fifteen (15) years of pharmaceutical, clinical drug development, project management and/or medical field experience. Or + Master's… 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
- 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
- Bristol Myers Squibb (Devens, MA)
- …Drive the evolution of BMS Information architecture, adhering to information and data architecture principles, guidelines, and standards in partnership with ... their personal lives. Read more: careers.bms.com/working-with-us . The Information and Data Architecture discipline has a critical importance for Bristol Myers… 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
- 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
- Merck (Boston, MA)
- …+ Develops, updates, and maintains GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contributes to the development ... . It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the … 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
- 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
- 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
- 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)
- …country clinical research law & guidelines. + Excellent understanding of Global , Country/Regional Clinical Research Guidelines and ability to work within ... ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as… 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
- BD (Becton, Dickinson and Company) (Boston, MA)
- …and relationship building skills. + Ability to collect, analyze and present clinical data . Must be proficient with computer (Word, PowerPoint, Excel, ... **Job Description Summary** The Clinical Manager, Product Training and Education for Urology...goals. The specialist will train according to company compliance standards and bears the responsibility of delivering live and… more