- Merck & Co. (Rahway, NJ)
- …(eg, database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical ... Job DescriptionJob SummaryThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in one or several programs. Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and ... (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations . This position develops ... SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews ...with CROs to execute study start up processes.ResponsibilitiesGlobal PV Operations Representation on Clinical Study Teams: Represents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. Responsibilities Study Strategy : Provides the ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Merck & Co. (Rahway, NJ)
- …team in the role of Director. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC...-IO on Oncology development teams. Framing critical questions and strategy for optimizing model-based analyses on programs. Developing and… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional ... Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a team that will build… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, ... sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as...data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional ... and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems ... technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.--An established reputation for scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan for select… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... for next-generation biologic manufacturing processes.Apply rigorous scientific principles and data analyses to solve challenging problems related to developing… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within its ... process, and technology together to generate business value from clinical trials data . Our operational model is exemplified through execution and innovation.… more
- AbbVie (Florham Park, NJ)
- …bringing people, process, and technology together to generate business value from clinical trials data . Our operational model is exemplified through execution ... in oversight of vendors and provides feedback related to clinical trial operations , issues, and trends in...desired. + Must have 8+ years of pharma / clinical research / data management / health… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Abbvie Clinical Data Strategy and Operations (CDSO) is best in class team ... is exemplified through execution and innovation. The Director of Clinical Data Strategy & Operations (CDSO) oversees the Oncology therapeutic area . This… more
- Merck (Rahway, NJ)
- …Trial Data Manager: + Creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... the development of, and ensures adherence to, our Company clinical data management procedures. Interacts with staff...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Touro University (New York, NY)
- …an accomplished IT professional, you will join our organization as a Director of Clinical IT Operations . This role requires an individual with strong technical ... system wide leaders and technical engineers, execute a comprehensive strategic plan for clinical IT operations that supports the University System's mission and… more
- Merck (Rahway, NJ)
- …if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO ... company's diverse development portfolio. It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with… more
