- Merck & Co. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management/monitoring activities in compliance ... 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 or… more
- Merck & Co. (Rahway, NJ)
- … Specialist may be responsible for but not limited to:Job ResponsibilitiesMaintain clinical trial files (including eTMF), project processes, tracking systems, ... and external stakeholders (eg, study sites, committees) in support of clinical trial objectivesCore SkillsPharmaceutical, research, medical, and/or clinical… more
- Merck & Co. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, 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 & Co. (Rahway, NJ)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP) will be responsible for...strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the… more
- Merck & Co. (Rahway, 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.This...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research… 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
- Novo Nordisk Inc. (Stamford, CT)
- …of clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… 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)
- …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)
- …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)
- … 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 (Rahway, 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
- ThermoFisher Scientific (New York, NY)
- … 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
- 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 (Rahway, NJ)
- **Job Description** With support of Sr CRA ( Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager throughout all ... of site relationships through all phases of the trial . + Performs clinical study site management/monitoring activities in compliance with ICH-GCP,… more
- J&J Family of Companies (Raritan, NJ)
- …will actively participate in or lead aspects of, medical review of clinical trial data, including adverse events, efficacy data, patient screening/eligibility ... Associate Director, Clinical Project Scientist -...Safety Management Plans * Performs medical monitoring/reporting, evaluates ongoing clinical trial data * Liaise with external… more
