- 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
- 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)
- …or Master's plus minimum 7 years SAS programming experience in a clinical trial environmentExperience leading large and/or complex statistical programming ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures,… 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. (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)
- … 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
- On-Board Companies (NJ)
- … Clinical Research experience* Working knowledge of IRT* Working knowledge of Clinical Trial Management Systems* Working knowledge of clinical supplies* ... On-Board Administrative is hiring a IRT Business Associate - REMOTE For immediate consideration please send your...are Located About Us: On-Board Services, Incorporated is an on- site contract service provider for a local manufacturing entity… 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
- 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 (Rahway, 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program. The ... impact. Join Gilead and help create possible, together. **Job Description** The Associate Director, Clinical Records & Information Management will partner with… 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 (Rahway, NJ)
- …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
- IQVIA (Parsippany, NJ)
- …may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive,...site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more