- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and external ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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 .Drug...with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of… more
- Insmed Incorporated (New York, NY)
- …and/or product support of appropriate prescribing, improved patient outcomes.Present data on Insmed products to HCPs including physicians, academic institutions, ... knowledge and competency of Insmed therapeutic disease states, products, and competitor data . Serve as a local medical and scientific resource to Insmed for… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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 aspects… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a ... of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure...MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding 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 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
- Bristol Myers Squibb (Madison, NJ)
- …design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data . Associate Director drives the ... development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director ...medical terminology used in the analysis and submission of clinical data + Broad expertise in statistical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external ... master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
- Bristol Myers Squibb (Summit, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data … 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Clinical Pharmacology - Virology** **_*This is ... the respective cross-functional study team. + With input from others, designs clinical pharmacology study protocols, study data analysis, modeling and simulation… more
- Pfizer (New York, NY)
- The Associate Director , Clinical Diagnostics will support development of Diagnostics and Global Diagnostic Strategies across therapeutic areas. We are ... sound diagnostic testing strategies, effective implementation of assays into clinical trials, and communicating data and program...of assays into clinical trials, and communicating data and program impacts to key stakeholders and project… more
- IQVIA (Parsippany, NJ)
- This role is aligned with IQVIA's Centralize Outsourcing Operations Hub (COOH) team. The Clinical Training Manager or Associate Director will be responsible ... for the development and implementation of learning programs for clinical -based roles with patients and healthcare providers in both the field-based and virtual… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …of hard copy and/or electronic solutions for data acquisition in MTPA clinical development studies. The Associate Director functions in a department ... evidence, and creating hope for all facing illness. The Associate Director , Data Management is...and leads all operational aspects of the projects in Clinical Data Management. **Responsibilities** + Responsible for… more
