- 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …be responsible for driving the strategy for Takeda's global data standards , processes, and technologies across the clinical data continuum for ... to patients worldwide. Join Takeda as an Associate Director, Clinical Data Standards where you...quality of deliverables and global data interoperability. You will also actively participate in and… 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 (Boston, MA)
- Description: POSITION SUMMARY The Clinical Data Specialist III (CDS III) independently plans, conducts and reports the data management portion of large, ... options. The CDS III position is an experienced manager supporting Clinical Data Management (CDM) teams, coordinating projects, facilitating infrastructure… 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …Cambridge, MA or Zurich, Switzerland **About the role:** + Leads the global Clinical , Pharmacovigilance, and Medical Quality Compliance organization, providing ... + Serves as a senior strategic Quality Partner to various Compliance functions in Data Science Institute (DSI), Global Development Operations (GDO) and Global… 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)
- … clinical studies across all Convatec's business units. Reporting into the Head Global Clinical Operations, this role is the key representative for our Study ... budget; report metrics and out-of-scope activities to the Head Global Clinical Operations as required. + Analysing...+ Working 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
- 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
- Sanofi Group (Cambridge, MA)
- …efforts at a global or multi-country level (eg through digital/ real-world data / omnichannel solutions) + Experience in clinical research + Significant line ... in patient and scientific knowledge and insights to improve clinical care. We do this by generating and curating...solutions that address highest unmet needs. **Main responsibilities** The Global Medical Head of Immunology leads the Global… more