- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics ... disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). ... risk identification and mitigation planning for assigned clinical trial sites Drives and tracks site activation and start-up activities with clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that ... US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance...projects for NACD & Novo Nordisk (eg Investigators and site staff, vendors etc.). Establish and manage senior level… more
- Insmed Incorporated (Bridgewater, NJ)
- … Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the protocol ... section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.ResponsibilitiesAdditional representative responsibilities… more
- Merck (Trenton, NJ)
- …This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, ... Clinical Research, the individual is responsible to manage/oversee a team of CTCs( Clinical Trial Coordinator). As line manager the role is critical to… more
- Taiho Oncology (Princeton, NJ)
- …of timelines, budget, recruitment and country/ site selection strategies, and provision of clinical trial materials. + Serves as main study contact for the ... Associate Director, Clinical Operations Pleasanton, CA,...sites. + Responsible for the financial management of the clinical trial in conjunction with his/her supervisor… more
- ThermoFisher Scientific (Bridgewater, NJ)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... Impactful Work:** Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts...study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC… more
- Merck (Trenton, NJ)
- …and ensures continuity of site relationships through all phases of the trial . + Performs clinical study site management/monitoring activities in ... Manager, acts as primary site contact and site manager throughout all phases of a clinical...clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... clinical monitoring and required reporting, including pre-study visits, site invitation visits, routine monitoring visits (both onsite and...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies ... based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and … more
- Bristol Myers Squibb (Princeton, NJ)
- …the development and implementation of innovative strategies and technologies for clinical trial programming. A ssociate Director develop collaborative ... the development and implementation of innovative strategies and technologies for clinical trial programming + Independently develops, validates, troubleshoots,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely...compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity… more
- Bristol Myers Squibb (Princeton, NJ)
- …aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape ... Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Bristol Myers Squibb (Princeton, NJ)
- …management within a specific therapeutic area(s) and is accountable to manage clinical trial vendor partnerships that supports alliance and outsourcing ... management across multiple service categories of clinical trial activities in R&D. Key Responsibilities...out the highest potential of each of our colleagues. **On- site Protocol** BMS has a diverse occupancy structure that… more
- Merck (Trenton, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck (Trenton, NJ)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas....seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director of Biostatistics is a member of cross-functional development teams ... supporting neuroscience therapeutic area, and contributes to trial design, protocol development, analysis, planning, interpretation of results, and preparation of… more
