- 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck & Co. (North Wales, PA)
- …of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required Experience and Skills: Experience leading large… more
- Merck & Co. (North Wales, PA)
- …via initiatives, mentoring, process improvements, and/or innovationsStrong knowledge of clinical trial methodology, statistical concepts, and evaluation and ... working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday...or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working… 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
- J&J Family of Companies (Spring House, PA)
- …Physician (MRP) and/or Safety Management Team (SMT). + Reviews and interprets clinical trial data to enable timely internal decision-making and external ... Associate Director, Translational Clinical Medical Lead...+ Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is required. + Ability… more
- Abbott (Manhattan, NY)
- …of trends, clinical trial enrollment, and ICH-GCP and clinical research application Adheres to specified site nomination, qualification, and startup ... clinical staff (eg, operations management, study team, Site Contracts Associate ), as needed. **Manage all...needed, provide clinical and technical expertise for clinical trial procedure support + Attend study… 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 (Cranbury, 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
- Merck (North Wales, PA)
- …members including clinical directors and study managers to lead/support clinical trial scientific activities. **Job Responsibilities** + Responsible for the ... clinical protocol(s). + Serves as the lead clinical scientist on the clinical trial...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… 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
- Hackensack Meridian Health (Neptune, NJ)
- …works under the general supervision of the principal investigator responsible for the clinical trial (s) to which is assigned. **Responsibilities** + Acts as ... on each protocol and each patient participating in a clinical trial protocol in the clinical...SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified … more
- Merck (North Wales, PA)
- …stakeholders including the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, Outsourced Trial ... and improve lives. **Position Description:** Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist… more
