- Merck (Rahway, NJ)
- …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
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …as analysis reporting in a global arena. + Strong knowledge of industry clinical data standards and processes (eg, CDISC: CDASH/SDTM/ADaM, SDSP) and well ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director, Clinical Data Standards is a leadership role with oversight… more
- Merck (Rahway, NJ)
- **Job Description** The Associate Vice President, Global Data Management & Standards (GDMS) is responsible for ensuring that all clinical data ... standards and platform governance. **Primary Responsibilities:** + Ensures Clinical Data Management products and services are...case processing activities. + Sets vision and strategy for Global Data Management & Standards … more
- Pfizer (New York, NY)
- …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
- Merck (Rahway, NJ)
- … Data Manager: + Creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine ... facilitates cross-functional decision making, and performs risk management. + Represents Global Data Management on cross-functional trial teams and in… more
- Merck (Rahway, NJ)
- …the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations, Process & Systems (OPS) ... is an excellent opportunity to be part of a global process and engage colleagues worldwide. Key learning objectives/experiences...surveillance activities for new and revised FEP + Prepare data for intake into the central tool for managing… more
- Stryker (Mahwah, NJ)
- …As the **Senior** **Clini** **cal Data Manager,** you will be the clinical data management expert within the Joint Replacement organization managing large ... databases are in accordance with internal and external established clinical trial and regulatory standards , and local...+ Train internal and external collaborators in study specific clinical data management processes, the CRF, EDC… more
- Pfizer (New York, NY)
- …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
- AbbVie (Florham Park, NJ)
- …bringing people, process, and technology together to generate business value from clinical trials data . Our operational model is exemplified through execution ... study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at both the program...desired. + Must have 8+ years of pharma / clinical research / data management / health… more
- Merck (Rahway, NJ)
- …requirements) of the planned Clinical Study Report. As part of the Global Data Management and Standards organization, the Operational Excellence intern ... to see if we are the right company for your long-term goals. Clinical Data Management Operational Excellence is looking for talented and motivated students for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing the multiple ... (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus...in Clinical Development, Asset & Portfolio Management, Global Clinical Operations, BDM and DLT members.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** Provide support for all aspects of Global Clinical Operations with a high degree of quality in the ... Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This ... clinical study safety reporting and activities. + Global Clinical Study Start-Up Documentation: Reviews all...the project and/or study level as it relates to data capture and reporting. Establishes EDC standards … more
- Bristol Myers Squibb (Summit, NJ)
- …teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety. This leader will sit ... Clinical Quality Assurance function and ensuring the highest standards of quality and compliance in clinical ...role is a key contributor in advancing our overall Global Quality vision and strategy. **Key Responsibilities** + Lead… more
- Sanofi Group (Bridgewater, NJ)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. **Responsibilities** + Study Strategy: Clinical study ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- AbbVie (Florham Park, NJ)
- …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
- Pfizer (Pearl River, NY)
- …related to the conduct of clinical studies and the management of clinical data and especially any large-scale projects around innovating those functions. ... (with use of technology) and in compliance with regulatory standards . The individual must be open to change and... Clinical Operations, Clinical Design, and Clinical Research + Expertise in problem solving, data… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and ... Clinical Development. **Responsibilities** + Designs and leads clinical trial sample testing activities and data ...and implementation of biomarker assays in support of multi-site global clinical trials is preferred. **Competencies** +… more