- 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
- 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
- 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)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk Inc., (NNI) Procurement Methodology through Category Management and Strategic Sourcing activities. This position will ensure the acquisition ... of high- quality goods/services at the best possible prices by negotiating...opportunities for operational improvements and seeks agreement through consensus management . Relationships Reports to an Associate Director / Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …on dermatology, ophthalmology and onco-dermatology. Description: Sun is seeking a Sr. Manager , Clinical Outsourcing within its Clinical Outsourcing Team ... in Princeton, NJ. The Sr. Manager , Clinical Outsourcing will report into Sr. Director, Clinical... trial outsourcing, vendor selection and contract negotiation, vendor management , and reporting process for Sun Pharmaceutical's clinical… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager 's Job Title:Head of BDMDepartment Head Title:Associate VPDoes ... Main responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …portfolio or specific therapeutic areas from Phase 1 through life cycle management . Provides oversight of statistical activities performed by direct reports or staff ... the global function to support drug development and life cycle management . Represents the function in global regulatory/heath authorities' meetings. High-level… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Job Title: Head of Clinical Data Management Job Grade: G6/G7 Department: Biostatistics and Data Management FLSA Classification: Manager 's Job Title: Head ... Main responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… more
