- 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
- 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)
- …(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
- 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …and Key Performance Indicators (KPIs). This role works closely with the Clinical Program Operations Leads, Clinical Trial Managers/Leads (US ... finalization of materials, and distribution to executive leadership.Manages vendor(s) for clinical trial data visualization dashboards to ensure accuracy of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …liaise with Daiichi Sankyo QA on audit activitiesProvide oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in...primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy.… 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)
- …across all RD LFs. Define Cycle Times, Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain ... of Metrics, KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated ability to influence at all senior… 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial ... team members + May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician for provision and… more
- Actalent (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 ... the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence... system, Clinical project management, cro, irb, clinical study, regulatory documents, clinical trial… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery in Clinical Experimental Sciences. This role applies ... plan, monitoring plan, monitoring oversight plan, etc. + Reviews site level informed consents and other patient-facing study start-up...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and … 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
- 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
- IQVIA (Parsippany, NJ)
- …may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF)… more
- IQVIA (Parsippany, NJ)
- …may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's ...**MINIMUM RECRUITMENT STANDARDS:** + **2.5 years of clinical research coordination experience at site level**… more
