- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help manage risk ... leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership ... focus areas (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and COM). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF ... of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …specified-timelines with minimal oversight from the line manager.-Ability to proactively develop risk management and mitigation plans in the country and-resolve ... or higher) with a strong emphasis in science and/or Clinical Research Management /Administration.#MRLGCTO#eligibleforERPNOTICE FOR INTERNAL APPLICANTSIn accordance… more
- Merck & Co. (North Wales, PA)
- …position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate ... with global, cross- functional team-members including clinical directors and study managers to lead/support clinical trial scientific-activities.Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …implement modifications to risk assessment plans. Key Responsibilities Follow QRM (Quality Risk Management ) process per ICH Q9, identify the risk , ... This position will be responsible for leading and facilitating Risk Assessment Projects to the cGMP Clinical ...accountability of team members. Interface with all levels of management and ensure alignment throughout the organization. Be a… more
- Merck & Co. (Rahway, NJ)
- …ensures continuity of site relationships through all-phases of the trial.Performs clinical study site management /monitoring activities in compliance with ... primary site contact and site manager-throughout all phases of a clinical research study, taking responsibility of allocated sites.Develops strong site relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has moderate skills in continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and ... according 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)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in… more
- Merck & Co. (North Wales, PA)
- …relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations, ... is collected from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse events.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... clinical studies, post-marketing surveillance, signal detection and management...submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management… more
- Merck & Co. (Rahway, NJ)
- …or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Merck & Co. (Rahway, NJ)
- …improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide ... and analytical support to our Research & Development Division Oncology Clinical DevelopmentForecast grant spend as well as provide financial support related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …line with established targets and including communication of updates Ensures proactive risk identification and mitigation planning for assigned clinical trial ... minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required Relevant Novo Nordisk experience will apply where… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice and ... this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be ... Development Teams (PDTs) and collaborating with Section Heads, PDT Leaders, and Clinical Directors responsible for the design and medical monitoring of clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …performance against the budget.Maintains global integrated project plans, project timelines, risk management , plans and communication plans. Supports scenario ... formal presentation to senior management .Generates and maintains high quality risk management and communication plans. Independently identifies issues and… more
- Merck & Co. (Rahway, NJ)
- …responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP service providers ... performing manufacturing, packaging, labeling, analytical testing, and distribution supporting the clinical supply chain on behalf of our company. Key activities… more
