- 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 data ... (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level… more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Clinical Development will have global or ... based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable... content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global ... Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and… 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
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty...execution of strategic global communications programming in support of clinical data and regulatory milestones as well… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Statistical Programming manages the statistical programming group within the therapeutic area(s). The incumbent oversees all activities, ... you if: You have 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related… more
- IQVIA (Bridgewater, NJ)
- …driven by our dedication to healthcare and our passion for technology. As an Associate Director , Business Analysis based out of IQVIA Bridgewater, NJ Offices, ... by processing over 100 billion healthcare records and 60+ petabytes of unique data annually, we are laying the foundation for a radiant evolution in healthcare.… more
- AbbVie (Branchburg, NJ)
- …demonstrated, for example, through a peer reviewed publication (preferred) *Effectively analyze pre- clinical and clinical data (required) *Background in ... safety surveillance and authorship of PV documents *Analyze and interpret pre- clinical and clinical safety data and communicate the analysis and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative ... Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields from a ... activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. **Responsibilities** **Change Requests for PV Systems** +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data ....with data manager to ensure high quality data . + Drug Development Strategy: Provides input to multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data ....with data manager to ensure high quality data . - Drug Development Strategy: Provides input to multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. **Functional Expertise:** ... DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure...(CMC) or equivalent preferred **Experience:** + 4+ years of clinical data management medical coding experience in… more
- Interstate Blood Bank (Lehigh Valley, PA)
- …responsible for driving sales and business development activities related to clinical biospecimens and biobank services. This role involves building and maintaining ... Any additional activities that support company objectives as determined by the Director of Business Development. **Knowledge, Skills, and Abilities:** + Must have… more
- St. Luke's University Health Network (East Stroudsburg, PA)
- …Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety. + ... PT department staff and others + Participates in QI data collection/planning + Attends multi-disciplinary meetings as applicable +...+ Cleans and orders supplies, as assigned by facility director , for daily operations + Other related duties as… more