- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data on ... areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in one or more clinical trial operations functions / sub-functions ( Data Management , Biostatistics, Clinical Science) preferred Travel:Ability to travel up ... research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is… 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)
- …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)
- …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
- 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
- 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
- Bristol Myers Squibb (Trenton, NJ)
- …start up period (locally) * Investigator Meeting participation and preparation * Ensures data entered in Clinical Trial Managements Systems is current and ... Read more: careers.bms.com/working-with-us . Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . Position Title: Executive Director, Global Trial Management , TA Head Immunology/CV Functional Area Description: ... The general manager for all strategic and executional activities within a...This role reports to the Vice President of Global Trial Management (GTM) within Global Development Operations… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as an integral member ... team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis Oncology… 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …from study start to database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership role considered essential ... lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** Clinical Data Management k ey focus is to...end-to-end Data Management activities, manages data currency throughout the trial , and overall… more
- Taiho Oncology (Princeton, NJ)
- …with secure randomization processes, if applicable, and subsequent efficient and effective data management . + Ensure compliance with and adherence to the ... management . + Liaise with the Trials Steering Committee, Data Monitoring, and Ethics Committee as required. + Provide...Skills, and Abilities: + 3-5 years of relevant clinical trial management and leadership experience in the… more
- J&J Family of Companies (Raritan, NJ)
- …Mentor & support onboarding of new team members, particularly those in Trial Management . Foster employee engagement, inclusion, and Credo Behaviors. **Principal ... & Johnson, we all belong. The Lead Clinical Project Manager is responsible for the creation and management...Trial Leaders, Clinical Trial Managers, Clinical Trial Assistants, DAS Leaders, Trial Management… more
- Edwards Lifesciences (Trenton, NJ)
- …calculation + Extensive understanding in statistical methodologies related to clinical trial designs, statistical modeling, data analyses, development SAP, SOPs, ... ** Manager Biostatistician - Transcatheter Mitral & Tricuspid Therapies...aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor… more
- J&J Family of Companies (Titusville, NJ)
- …our people can reach their potential. At Johnson & Johnson, we all belong. The Manager , Clinical Trial Leader Project Management (CTPM) is responsible for ... Manager , Clinical Project Manager , Oncology (1...vs. plan and will identify potential issues for the trial through active management of the study… more
- Bristol Myers Squibb (Princeton, NJ)
- …data for specific trends + Develop Data Review Plan in collaboration with Data Management + Ensure CRF design adequately supports data collection in ... with instruction + Provide regular and timely updates to manager / management as requested + Develop Protocol and...alignment with the protocol in collaboration with Data Management /Programming + Submit clinical contributions to… more
