- Novo Nordisk (Plainsboro, NJ)
- …NACD. Ensure business needs are met through alignment of business plans and operational need within the Therapy Area and OED to regarding continuous efficiencies and ... for managing internal and external strategic collaborations to optimize Operational Excellence and Delivery (OED) performance by building relationships, developing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Function as technical resource to the study teams for data visualization and reporting tools. - Operational Efficiency / Continuous Improvement: May participate ... rare diseases and immune disorders. **Summary** This position supports Daiichi Sankyo's Risk Based Data Monitoring and Validation strategy. This role will assist in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …level. Responsible for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting , and close out) including ... areas centered around rare diseases and immune disorders. **Summary** Senior clinical operational leader accountable for operational planning and execution of… more
- IQVIA (Durham, NC)
- …Global Clinical Team and GCO objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management ... clinical studies of standard to medium complexity and priority per the Operational Execution Plan (OEP) and clinical study protocol. The Senior Study Leader… more
- Astellas Pharma (Northbrook, IL)
- …finance. Member of team for quarterly budget forecasting for program. Identify tactics at risk and develop plans to mitigate risk of tactics identified. Maintain ... adherence to scope, budget, timelines, and risk mitigation plans. Responsible for vendor contracting for relevant tactics, management, and assess performance and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to relocate._ The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned ... tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member...Plan. + Responsible for accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and… more
- Pfizer (Cambridge, MA)
- …Sponsor, expectations, and any emerging information. + In support of Ignite Operational Lean, ensures appropriate information (including risk ) is readily ... with Pfizer preferred Clinical Research Organization (CRO)/Vendor responsible for the operational management of Pfizer Ignite clinical studies and team leadership of… more
- Randstad US (Cambridge, MA)
- …to enable key discussions and decisions within the team. + Manage the planning, operational and reporting logistics of the MST (including but not limited to: ... planning efforts of MSTs, in maintaining oversight for the operational plans, execution strategies & critical path for the...collaboration with GMA functional teams. + Leads the project risk management process in the team and generates the… more
- GRAIL (Menlo Park, CA)
- …This role will help shape, and implement the safety strategy and safety risk management for all GRAIL products during the product development and post-market ... and other sources + Ensure timely and appropriate global reporting of clinical and commercial products + Develop a...and external teams + Leads and oversees ongoing safety risk -benefit assessments and provide support to Quality and Regulatory… more
- AbbVie (North Chicago, IL)
- …cross-functional study team. + Act as single point of contact & accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational ... & deliver data management tasks within timeline. + Utilize operational analytics & project management tools to optimize execution...quality & develop options & solutions, identify & mitigate risk and contribute to Risk Assessment &… more
- BeiGene (San Mateo, CA)
- …the Safety Management Plans + Lead Safety Science specific investigator training ** Risk Assessment, Regulatory Inquiries, and Periodic** ** Reporting ** + Lead the ... activities and contributes and assists in pharmacovigilance activities including benefit/ risk and regulatory activities and interactions._ **Essential Functions of… more
- BeiGene (Emeryville, CA)
- …and maintenance of the Safety Management Plans + Support investigator training ** Risk Assessment, Regulatory Inquiries, and Periodic Reporting ** + Analyze safety ... activities and contributes and assists in pharmacovigilance activities including benefit/ risk and regulatory activities and interactions._ **Essential Functions of… more
- Novo Nordisk (Plainsboro, NJ)
- …for CKAD and Rare Disease. Essential Functions + Provide strategic and operational guidance to ensure that trials are properly defined, planned, and executed ... operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution; accountable for maintaining pro-active approach to inspection… more
- BeiGene (Hopewell, NJ)
- …master plans, lead contractors for execution of validation work, develop risk assessments, support audits and inspections, write and implement Equipment, Facility ... and Process Installation/ Operational /Performance Qualifications (IQ/OQ/PQ), and write deviations, root causes, and corrective actions. This role also will lead… more
- Olympus Corporation of the Americas (Westborough, MA)
- …contracting, investigator training, IRB submissions, enrollment case monitoring & reporting , safety monitoring, risk management, closure, summation for ... ownership for delivering a wider portfolio of MSA assets into the DU operational processes. The DUMD role requires the application of prior clinical knowledge and… more
- Danaher Corporation (Sunnyvale, CA)
- Position Summary The Cepheid Chief Medical Officer is a critical role reporting directly into the President. This high visibility position is pivotal to our success ... and direct customer interactions as needed + Provides clinical input to Risk Assessments, Failure Mode Effect Analysis (FMEA), and Health Severity assessments within… more
- Amazon (Phoenix, AZ)
- …ensure appropriate clinical safeguards are implemented to mitigate customer and company risk . - Pharmacist verification to operational management and leadership ... Operations Manager partners with operations management, blending both a clinical and operational skill sets to assist in supporting the business and customer in… more
- Lilly (IN)
- …Clinical Pharmacologist (CP) participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of ... global clinical trials, the reporting of adverse events as mandated by corporate patient...pharmacology sourcing group. + Review and provide input to risk profiles and local informed consent documents as required,… more
- Lilly (Indianapolis, IN)
- …The AVP will also supervise the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process ... with clinical research staff in the design, conduct and reporting of local clinical trials (eg, sample size, patient...grants, and governance review interactions). + Review and approve risk profiles to ensure appropriate communication of risk… more
- Brockton Hospital (Brockton, MA)
- …resources to make a difference in the lives and health of our patients. Reporting to the Sr. Vice President, Patient Services, the Vice President of Pharmacy ... costs and supply chain related shortages, incorporating new technologies that enhance operational performance. + Directly responsible for clinical & operational … more