- Merck (Boston, MA)
- …great development and a chance to see if we are the right company for your long-term goals. Global Clinical Data Standards is a part of the Global ... Data Management and Standards division within Global Clinical Trial Operations. Our mission is...maintain a high-quality, transparent, reusable, and compliant set of clinical data standards that facilitate… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards . While the Clinical Data Standards ... realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,... standards for clinical operation and data flow, the Clinical Data … more
- Pfizer (Cambridge, MA)
- …data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data , applies standards , data review and query ... around the world. **POSITION SUMMARY** As part of the Clinical Data Sciences (CDS) group, an integral...Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization,… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategy for area(s) of responsibility and activelycontribute to and align with the overallCDM, Global Integrated Clinical Trial Data Services,and Global ... future at Takeda. Join us as the Senior Director, Clinical Data Management (Oncology & Cell Therapy)...towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Data Sciences comprises of the Clinical Data Engineering (CDE) and Clinical Data Standards . While the Clinical Data Standards ... realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,... standards for clinical operation and data flow, the Clinical Data … more
- Pfizer (Cambridge, MA)
- …What You Will Achieve It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical ... data and records. You will be organizing clinical data forms from therapeutic groups and...operational excellence in collaboration with partners for application of standards , data acquisition, proactive data … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …drive Takeda's Data and Digital mission by developing and adopting clinical and medical technologies that align with business needs, best practices, and ... + Partner with DD&T and business stakeholders to enable the consumption of Enterprise Clinical & Medical technology standards . + Act as the SME (tools, features,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Enable stakeholders (both within and outside of Takeda) to consume Takeda's Global Clinical Trial Recruitment technologies. + In select instances, enable, ... true to the best of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** As the Global Platform Manager for Clinical Trial Recruitment working in the… more
- Sanofi Group (Cambridge, MA)
- …Lead discussion at meetings with regulatory agencies. + Ensure clinical data meets all necessary regulatory standards . **Qualifications:** + Medical Doctor ... the clinical development plan, designing and executing clinical trials, analyzing trial data , interacting with...internal decision making. CRD will work closely with the Global Project Head, Research Scientist, Clinical Pharmacologist,… more
- Sanofi Group (Cambridge, MA)
- …medical spokesperson for the studies and project + Ensures clinical data meets all necessary regulatory standards + Supports registrations, label submissions ... **About the Job** We are an innovative global healthcare company with one purpose: to chase... dissemination** + Ensures timely submission and dissemination of clinical data + Supports the planning of… more
- Takeda Pharmaceuticals (Boston, MA)
- …act as an enterprise level partner responsible for the lifecycle management of clinical bioanalytical (PK, ADA) and biomarker samples, data , and specialty lab ... and final sample disposition) in collaboration with relevant stakeholders including Data Management, Clinical Operations and Quality Assurance. + Utilize… more
- AbbVie (Boston, MA)
- …Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business ... therapeutic area. *Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for… more
- Sanofi Group (Cambridge, MA)
- …documents, and addresses queries from regulatory bodies, IRBs, and ethics committees. Reviews clinical data and ensures accuracy for final clinical study ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...an advantage + Understands and keeps updated with the pre- clinical , clinical pharmacology and data … more
- Sanofi Group (Cambridge, MA)
- …what you thought was possible. Ready to get started? **Job Summary** Reporting to the Global Project Head, the CRD leads clinical trial strategy and execution of ... Research Director** **About the Job** We are an innovative global healthcare company with one purpose: to chase the...PSP/PIP + Participates in Advisory Committee preparation + Scientific data evaluation and authorship + Authors clinical … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …thinking for innovative strategies in developing and disseminating Takeda's scientific and medical data at the Global level.** **Development of the global ... process, clinical trial design and execution, statistical methods, and clinical trial data reporting requirements.** **Knowledge of the scientific… more
- Merck (Boston, MA)
- …project management skills **Preferred Experience and Skills:** + At least 5 years global or US medical affairs or clinical development experience with proven ... **Job Description** The Executive Director, Global Medical and Scientific Affairs (EDMA) GYN Malignancies...Brand and V&I Outcome Research Team leads to define clinical development plans and brand strategies for assigned TAs… 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
- Takeda Pharmaceuticals (Boston, MA)
- …and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling. + Knowledge of Health Authority audit ... Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, ie, US and EU (CP,… more
- Teleflex (Boston, MA)
- Clinical Affairs Specialist, MCS (Remote) **Date:** Sep 23, 2024 **Location:** Boston, MA, US **Company:** Teleflex **Expected Travel** : More than 50% **Requisition ... ID** :11045 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by...make a difference in patients' lives. **Position Summary** The Clinical Affairs Specialist, MCS augments the sales process for… more
- Actalent (Boston, MA)
- …review, creating study manuals, ICFs, and designing CRFs. + Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing ... that study documentation is maintained according to applicable regulations, industry accepted standards , and SOPs that govern clinical studies. REQUIREMENTS: +… more