- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of concern and bring to supervisor's attention.Track study metrics such as site start -up, Investigator/ site performance, recruitment, regulatory documents, ... 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)
- …for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start -up, conduct, reporting ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and...file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc) ahead of study start . Oversee CRO study ... 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 and ... 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
- Merck & Co. (Rahway, NJ)
- …mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small ... of the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team member… more
- Actalent (Basking Ridge, NJ)
- …CRO Oversight Monitoring (CROOM) visit output Track study metrics such as site start -up, Investigator/ site performance, recruitment, regulatory documents, ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Actalent (Basking Ridge, NJ)
- … Start Up Associate ManagerJob Description + The Associate Manager, Site Start Up - Clinical Trial Insurance Leader is responsible for acquiring ... and quality. Hard Skills + Bachelor's Degree + 5+ years in site start up/study start up + Clinical Trial Insurance Experience + DIA TMF Reference model… more
- Bristol Myers Squibb (Princeton, NJ)
- …Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start -up Specialists, Site Contract Leads, Vendor Operations Managers, Regional ... procedural requirements necessary for US investigative trial sites to conduct clinical trials, with accountability of executing these activities from study startup… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …concern and bring to supervisor's attention. Track study metrics such as site start -up, Investigator/ site performance, recruitment, regulatory documents, TMF ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- ThermoFisher Scientific (Bridgewater, NJ)
- …colleagues within our PPD(R) clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study ... **Discover Impactful Work:** Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on- site visits… more
- Bristol Myers Squibb (Princeton, NJ)
- …administrative and business activities related to the conduct of clinical trials (registrational and non- registrational /Investigator Sponsored Research Studies) ... with investigative sites from study start -up to study closure. **Key Responsibilities and Major Duties...and non-drug (Lab kits, ECG) importation to support study site + Complete all payment activities including preparing invoices,… more
- IQVIA (Parsippany, NJ)
- …(CRF) completion and submission, and data query generation and resolution. May support start -up phase. * Ensure copies/originals (as required) site documents are ... basis. * If applicable, may be accountable for site financial management according to executed clinical ...for site financial management according to executed clinical trial agreement and retrieve invoices according to local… more
- IQVIA (Parsippany, NJ)
- …(CRF) completion and submission, and data query generation and resolution. May support start -up phase. * Ensure copies/originals (as required) site documents are ... basis. * If applicable, may be accountable for site financial management according to executed clinical ...for site financial management according to executed clinical trial agreement and retrieve invoices according to local… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Reviews site level informed consents and other patient-facing study start -up materials + Oversees setting up and maintenance of study systems including but ... The **Assoc Manager Clinical Study** (CSAM) role supports the Clinical...+ Monitors recruitment and retention + Monitors progress for site activation and monitoring visits + Supports data quality… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc) ahead of study start . Oversee CRO study ... 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
- Bristol Myers Squibb (Madison, NJ)
- …integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock . **Position Summary / ... R&D pipeline . This role may report into Director, Clinical Data Management or Associate Director, ...out the highest potential of each of our colleagues. **On- site Protocol** BMS has a diverse occupancy structure that… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …effort for clinical supply management functionality. + Monitors and manages clinical supply activities through IRT from study start -up through study closure. ... compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity...+ Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use),… more
- Merck (Rahway, NJ)
- …mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small ... the MACS EDFE Leader include the following: The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team member supporting… more
- Bristol Myers Squibb (Summit, NJ)
- …sites and CMOs. + Accountable for establishing and managing the technical transfer start -up and spend budgets for assigned manufacturing site and the associated ... impact + Manage inventory risk assessment process for inventory located at manufacturing site . Lead efforts to manage and execute risk mitigation plans. + Lead cross… more
- Bristol Myers Squibb (Princeton, NJ)
- …**Drives the clinical trial feasibility process and decision-making for country, site , and patient allocations on behalf of a region in collaboration with global ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Associate Director, Regional Delivery Lead (RDL) **Position Summary:** **The … more