- Aequor (New York, NY)
- …Supply Chain Business Lead (SCBL) is responsible to advance and grow the Global Clinical Supply (GCS) business of delivering clinical supplies to patients. The ... and externally, enables colleagues and leaders to effectively develop flexible and creative clinical supply solutions in support of the delivery of 's portfolio. The… more
- Brooklyn Center (New York, NY)
- Brooklyn Center is hiring a Registered Nurse (RN) Unit Manager in Brooklyn, NY. We are now offering a $5,000 Sign-On Bonus Duties: Handle all supervisory duties for ... employee policies and procedures Mentor less experienced nurses, offering clinical & career advice Maintain the standards of care...of care for the unit Review Resident records & quality of care Monitor overall care & review individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness ... Strong knowledge of ICH-GCP relating to regulatory guidelines, and quality management principles. requiredExpert knowledge in Clinical Operations Phase 1 to… more
- Merck & Co. (Rahway, NJ)
- …accountable for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses ... clinical narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality , completeness,...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter ... immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality ... to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionClinical Operations in our Company Research Labs IT supports clinical trial operations, execution, and management . Our IT team operates as a ... Technical Lead to drive, oversee, and lead the development and maintenance of our clinical trial risk management applications.- This role demans a blend of… more
- Merck & Co. (Rahway, NJ)
- …Facilitate equipment/system change controls, execute periodic reviews and support Quality Management System (QMS) activities.-Provide technical expertise, ... continuity.The FLEx sterile area supports the formulation and filling of clinical , stability, and developmental supplies for biologics and vaccines, including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …negotiation, preparation, and execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and ... management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability… more
- Eisai, Inc (Nutley, NJ)
- …information to make sound business decisions to build business cases that drive quality decision making and management processes.Travel is estimated at 30% of ... want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will...and logistics associated with the CE experience.Assist with the management of the CRC tracker to drive cross-functional accountability,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product ... pharmaceutical dosage forms preferred4 or More Years Solid understanding of quality management and continuous process improvement principles preferred… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... centered around rare diseases and immune disorders. SummaryThis position is responsible for supporting project management and operational activities as part of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical administrative support to the study teams and support interactions with the ... Quality Oversight measures. Responsible for staff training, performance management , setting individual employee goals and career growth opportunities.The … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is...complex data review listings and reports to support Data Management and clinical teams.Develop, implement and maintain… 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 ... research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with strong preference for study feasibility, and/or study design optimization and/or clinical operations project management preferably with a sponsor company at ... (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)
- …(eg clinical research & development, clinical science, clinical quality assurance, project management ) preferredStrong leadership, collaboration, ... Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle...the Global Training Office to create a CRO Alliance Manager account within our learning management system… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that standardize data definitions, implements quality rules, and aligns with quality management system required- 4 or More Years Some hands-on experience ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management , lineage capabilities and the data governance processes… more
