- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with Functional and… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all phases of the trial .Performs clinical study site management /monitoring activities in compliance with ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all phases of… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management /monitoring activities in compliance with ... Job DescriptionWith support of Sr CRA (Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... collection of diverse external data types.Advises Study Data Manager on complex vendor management...disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs ... This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance ... meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Novo Nordisk Inc. (Stamford, CT)
- …Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in one or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) required- Collaboration, ... Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements.-monitor and evaluate risks/issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, ... and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to improve organizational efficiencies and cost controls.Communication and Relationship Management - Leads contract related communication with vendors. Respond to ... appropriate utilization and application of advanced negotiation skills, partnership management and strong interpersonal skills to support and advance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to ensure high ... QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …individual to join our company, in the Clinical Operations Department as a **Clinical Trial Manager /** **Senior Clinical Trial Manager ** who ... vendor performance. + Reviews all operational study plans (project management plan, monitoring plan, communications plan, TMF plan) for...Clinical Operations is required; 2+ years as a Clinical Trial Manager + CNS experience is required… more
- IQVIA (New York, NY)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor management becomes ... the catalyst for advancing medical breakthroughs. As a **Clinical Trial Vendor Manager ** , you'll play a...our high standards of quality and service. + **Risk Management Guru:** Proactively develop and maintain vendor-related risk maps,… more
- Actalent (Armonk, NY)
- …of the Global Trial Optimization function through process initiatives and change management activities. + Partner with Data and Analytics function to review ... LOCAL TO GO ONSITE 2-3X PER WEEK** Summary: Senior Manager , Global Trial Optimization (GTO) will lead...level feasibility processes to generate high quality and timely data to inform study design, optimal geographical placement and… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives by ... standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. * Manage clinical aspects of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with Functional and… more
- Vitalief (New Brunswick, NJ)
- …Research Center, performs patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management . and other clinical trial ... Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management , and ensuring Serious Adverse Events… more
