- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Data Management (CDM) serves as Therapeutic Area Head providing Clinical Data Management leadership to Data ... support of Regeneron key development programs. Works with Sr Director and Executive Director to set department...Manager (CCDM) experience. + Minimum of 12+ years of clinical data management experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for ... Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with… more
- Lilly (Branchburg, NJ)
- …$111,000 - $162,800 **Position Description:** The Clinical Trial (CT) Supply Management Associate Director will provide operational leadership of clinical ... and mitigate risk, and perform portfolio analyses through robust data and metrics analysis + Lead and ensure operational...At least 5 years work experience in supply chain management or clinical development **Additional Preferences:** +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part ... The Director Clinical Sciences, Hematology, leads in... data review + Ensures consistent first line medical/ clinical data review techniques and conventions across… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management 5. Work with Biometrics to ... will monitor clinical studies, review and interpret clinical trial data , provide input into ...veteran status, disability or any other legally protected status. Director Clinical Development - Base Salary range… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan (IDRP) + ... ** Director , Clinical Development** **Join a Legacy...(MM): + Provides oversight to the CRO MM for clinical data review activities + May support… more
- Sanofi Group (Bridgewater, NJ)
- …meetings as the medical spokesperson for the studies and project + Ensures clinical data meets all necessary regulatory standards + Supports registrations, label ... you thought was possible. Ready to get started? The Clinical Research Director (CRD), Dupilumab, Immunology and... dissemination** + Ensures timely submission and dissemination of clinical data + Supports the planning of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …supplier management activities, and stakeholder engagement activities for the Clinical Laboratories Category as assigned. + Works independently to drive value in ... Accountabilities:** + Accountable for leading, defining, and implementing the global Clinical Laboratories Category strategy to serve global and regional business… more
- Sanofi Group (Bridgewater, NJ)
- …on patients' lives. **Main responsibilities:** As a Senior Statistical Project Leader ( Director ) in our Statistical Innovation Hub, you will serve as the expert ... for defining novel digital endpoints or re-engineering existing endpoints from digital Clinical Outcome Assessments (COAs). You will act as a go-to person in… more
- IQVIA (Bridgewater, NJ)
- …directed at decision-makers and decision influencers at existing and new clinical sponsors. Essential Functions + Actively prospect and leverage potential new ... CRM system. + Prepare sales activity report for Sales Management as required. + Serve as a liaison between...Excellent analytical skills in assessing and interpreting customer business data + Ability to maintain demanding timelines. + Ability… more
- Sanofi Group (Bridgewater, NJ)
- …and clinical study reports. + Oversee the analysis and interpretation of clinical and real-world data to generate meaningful insights. + Ensure the accurate ... affairs, and real-world evidence generation. + Demonstrated experience andknowledge of clinical trial design, biostatistics, and data analysis. + Demonstrated… more
- Sanofi Group (Bridgewater, NJ)
- …+ Fluent in English **Knowledge And Skills Desirable But Not Essential:** + Clinical operations, statistical, data management and regulatory knowledge **Why ... Clinical Scientist's position is to support the Clinical Research Director (CRD) and/or clinical...focused, able to develop good practices, using a critical data -driven and risk management approach + Familiar… more
- IQVIA (Bridgewater, NJ)
- …lives and advance healthcare innovation across the US and Canada. The Associate Director of Project Management will direct and manage project(s) and/or ... ensure adherence to change control processes. + Supervise maintenance of project management information and data tracking systems. + May direct project… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of safety data between partners in relation to marketed and clinical products. **Strategic Partner Management :** Oversees Local/Global PV service providers ... around rare diseases and immune disorders. **Summary** Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts… more
- J&J Family of Companies (Raritan, NJ)
- …Be an active partner and core contributor of safety input to key regulatory or clinical documents including:- Risk management plans + Clinical Trial, EAP and ... Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology (Solid Tumor) to...including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment,… more
- IQVIA (Bridgewater, NJ)
- …partnerships with multiple teams: audience data , partnerships, client services, and data management to drive product enhancements. + Collaborate closely with ... MBA is preferred. + Experience and working knowledge of clinical data is preferred. + At least...management experience, preferably in a healthcare technology or data -focused organization, with a track record of driving high-performing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of data to ensure quality of results. **Service Provider Oversight & Management ** + Oversight of Data Request processing by Service Providers + Training ... + Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields from a… more
- Sanofi Group (Bridgewater, NJ)
- …guidance to internal Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to ... **Job Title:** US Medical Director , Mainline Vaccines **Location** : Bridgewater, NJ /...label updates and product Company Core Datasheet (CCDS) updates. ** Data Generation** + Work with R&D and Clinical… more