- 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
- 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)
- …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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start-up Specialists, Site Contract Leads, Vendor Operations ... and non-drug (Lab kits, ECG) importation to support study site + Complete all payment activities including preparing invoices,...work experience. + Experience in the use of industry Clinical Trial Management Systems and Clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- … Clinical Research or related work + Experience in the use of industry Clinical Trial Management Systems + Additional complex software application related to ... and non-drug (Lab kits, ECG) importation to support study site + Complete all payment activities including preparing invoices,...clinical trial research (ie electronic data capture… 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
- 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 (Basking Ridge, NJ)
- …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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …projects * Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects * ... R&D pipeline . This role may report into Director, Clinical Data Management or Associate Director, ...functional study team members to ensure on-going review of trial data currency, quality and completeness * Represents DM… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with Daiichi Sankyo QA on audit activities + Provide oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control Center ... 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
- Actalent (Basking Ridge, NJ)
- …Title: Study Start Up Associate ManagerJob Description + The Associate Manager, Site Start Up - Clinical Trial Insurance Leader is responsible for ... and guidelines. + Key responsibilities include maintaining and requesting clinical trial insurance, discontinuing insurance at study...in site start up/study start up + Clinical Trial Insurance Experience + DIA TMF… more
- Bristol Myers Squibb (Princeton, NJ)
- …- Supervise and coordinate the work assignments and performance of Trial Manager, Trial Specialist and Trial Associate staff assigned NRDG trials in the ... personal lives. Read more: careers.bms.com/working-with-us . **Title: Senior Manager, Clinical Operations Position** **Responsibilities:** + 7-10 years of pharmaceutical… 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
