- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end delivery of External ... drug development processes and global submissions.This position provides expertise within Data Management by partnering with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary The Associate Director, External Data Management , is accountable for the end-to-end delivery of External ... drug development processes and global submissions. This position provides expertise within Data Management by partnering with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourcing (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ... and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Nesco Resource (San Antonio, TX)
- …sites or third party delivery points.* Maintain records in compliance with PHMSA Control Room Management (DOT requirements).* Operators are considered ... whose headquarters are in San AntonioThey are hiring a Control Center Operator Would you be available...Compression, or Terminal Operations Systems.* Knowledge of (SCADA) Supervisory Control & Data Acquisition Systems related to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourcing (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key stakeholder peer functions ... and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reviewer metrics for quality control in support of clinical trial endpoint data , and collaborate with Imaging CRO on remediation efforts to ensure ... practices and record retention processes, particularly those used in Biostatistics and Data Management groups. Daiichi Sankyo, Inc. is an equal… more
- Merck & Co. (Rahway, NJ)
- …in Late Development Statistics.Interacts with Clinical, Regulatory, Statistical Programming, Data Management , and other company Research Laboratories Scientists ... :Solid knowledge of statistical analysis methodologies and experimental design.Strong project management skills. --Solid knowledge of- statistical and data … more
- Merck & Co. (Rahway, NJ)
- …Development Statistics.Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management , and other Company Research Laboratories ... scientific leadership in design and analysis of clinical trialsStrong project management skills. --Solid knowledge of- statistical and data processing… more
- Merck & Co. (Rahway, NJ)
- …supporting drug/vaccine projects.Interacts with Clinical, Regulatory, Statistical Programming, Data Management , and our Company's Research Laboratories ... projects.-Interacts with Academic Research Organization (ARO), Contract Research Organization ( CRO ) and external statistical consultants.This position may serve as a… more
- Spectraforce Technologies Inc (Alameda, CA)
- …visits. Participate in study startup activities. Prepare site for study startup, work with data management to draft CRF. Make sure protocols are in compliance at ... site to the ICH, and regulatory guidelines. They usually participate with data management team, to design case verification study There are cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on Study Team and collaborates as team member with other functions, ARO, CRO . Provides scientific input to Clinical Operations and other functions. This position ... Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings,… more
- BioAgilytix (Durham, NC)
- …Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical Operations group in support of ... need them.Our clients trust us to deliver excellence in data and bioanalysis and in this role and you...with between 2-10 years' experience working in biotech, pharmaceutical, CRO /CMO or similar organization; or Master's or PhD. with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …holistic perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO . Occasional interactions with ... the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population...Phase 3 registrational study(ies); Develop prospective contingency plans for management of key risks in a large study or… more
- Novo Nordisk Inc. (San Antonio, TX)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- BioAgilytix (Boston, MA)
- …marketing team, the Marketing Operations Manager will be responsible for the project management of all marketing campaigns, as well as digital marketing support for ... BioAgilytix, a global bioanalytical CRO . You will be responsible for receiving all marketing...necessary stakeholders, and addressing obstacles. In addition to project management , you will support our digital marketing efforts on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Distributor, Logistics and Demand Planning Operations (shipping, receiving, inventory control , customs clearance, supply / device management ) Responsible to ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...and create efficiencies. Manage end to end supply, order management , placement and delivery to US and CA warehouses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability to leverage digital data and analytics ... 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… more
