- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Management deliverables meet/exceed project/study team expectations regarding quality , time, and cost and that Data Management documentation ... to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead ... implementing best practices to help facilitate the inspection readiness mindset.Facilitates clinical quality risk identification and the necessary problem… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and ... execute study start up processes.ResponsibilitiesGlobal PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study… more
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... safety checks. Oversees and reviews area weekly and monthly Quality Control and maintain QC database. Set up and...up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data ... data review listings and reports to support Data Management and clinical teams.Develop, implement and… more
- Merck & Co. (Rahway, NJ)
- …materials - Prepare clinical narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality , completeness, and integrity ... close out of clinical trials within a program.- Clinical trials provide the required data which...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . --Your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that enable positive business outcomes.- Support the creation and us of policies, processes, data standards, data quality and enabling IT and digital ... research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a...emerging data management skills and capabilities, including data quality , master data management,… more
- Novo Nordisk Inc. (WA)
- …The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... services/tasks in support of the planning and implementation of quality driven clinical trials, in line with...relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...including advocating for good data governance, stewardship, data identification, and data quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules and data governance… more
- Aequor (New York, NY)
- …onboarding and oversight with business lines across GCS. Use technical operational and Clinical Development portfolio data to analyze and interpret past results, ... Supply Chain Business Lead (SCBL) is responsible to advance and grow the Global Clinical Supply (GCS) business of delivering clinical supplies to patients. The… more
- Option Care Health (Columbus, OH)
- …patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the ... all new referrals with speed and accuracy.Assist AVA Supervisor and Manager with special assignments as needed. Supervisory ResponsibilitiesDoes this position have… more
- Catalent (St. Petersburg, FL)
- …and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical ... and TLFs transfers for ongoing and complete trials, confirm data use and output quality , proactively ensure...and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position is required to work within a team focused on process, data /insight packages, outsourcing, and innovation. Depending on business needs this position may ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the ... centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence...including experience in one or more key functions (eg, clinical research, clinical operations, data … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed ... of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality ...related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , MSAT or ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
