- 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)
- …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)
- …according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, ... in accordance with DS standards. Act as the project manager of the clinical study team to...DS internal tracking systems are updated (eg Global Project Management System, GPMS). CRO and Quality Oversight:Responsible… 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)
- …regulations/EU 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
- Novo Nordisk Inc. (WA)
- …mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to ... to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability;… 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)
- …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)
- …allow access to unapproved medicines for patients with unmet medical needs.- Quality Management and Continuous Improvement: Provide guidance to teams during ... research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology… 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
- 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
- Catalent (St. Petersburg, FL)
- …employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… 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)
- …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 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
- Catalent (Manassas, VA)
- …at the site and across the company. Leads site-level initiatives for supplier management , supplier quality & supplier performance improvement as well as supports ... to help create engaging new products consumers will love.The Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... the Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer… 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global… 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
