- Merck & Co. (North Wales, PA)
- …the protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and ... to other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Merck & Co. (Rahway, NJ)
- …operating in 47 countries, responsible and accountable for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management ... Prepare clinical narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality,...intends to: Develop an understanding of the phases of clinical research . Develop an understanding of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... is a Clinical Science lead position and will lead a group...position may be at the executive director level or senior director level, depending on the scope and size… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical ... preferred 4 or More Years with PharmD/PhD preferred Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(KPIs) to analyze and report on diversity metrics in clinical trials- Monitor data and regularly communicate findings to senior leadership to make ... Stay abreast of industry trends and changes in regulations related to clinical research diversity and inclusion - Health Authority Interactions- Point of contact… more
- Tris Pharma (Monmouth Junction, NJ)
- …development plan for multiple, concurrent programs spanning all phases (I-IV)) of clinical research . The incumbent is responsible for establishing and overseeing ... NJ facility for an experienced MD to serve as Senior Director or Director, Clinical Development. Title...for one or more studies, as neededCollaborates with assigned Clinical Research Organization (CRO) and/or Medical Writer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Senior ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for… more
- Insmed Incorporated (Bridgewater, NJ)
- …our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 ... teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to… more
- Merck & Co. (South San Francisco, CA)
- …insights and complement internal pipeline. Monitor emerging biology and basic & clinical research within metabolic disorders & inflammation, and more broadly ... to direct reports and peers.Solid understanding of drug discovery and clinical development.Working knowledge of biomarker discovery, translational research , and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of assets and the enterprise as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across the ... areas/ disease states. Work collaboratively with cross-functional teams including research and development, regulatory affairs, and commercial teams, to align… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including patent term extensions, and SPCs.- Works closely with development teams to monitor results, new uses, etc. arising during research and development of ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and core campaign development to drive market share and revenue growth Market Research : Conduct market research and monitor competitive landscape to ... knowledge of the pharmaceutical industry, including medical, regulatory, and clinical processes In depth understanding of disease landscape, treatment modalities… more
- Edwards Lifesciences (Columbus, OH)
- …longer and healthier lives. Join us and be part of our inspiring journey. As the Senior Clinical Research Monitor , you will ensure trial patients' safety ... within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with...Knowledge of cardiovascular physiology and structural heart anatomy + Clinical research certification (ACRP or SOCRA, … more
- The Mount Sinai Health System (New York, NY)
- The Senior Clinical Research Monitor is responsible for performing ongoing internal reviews of research projects where human subject research is ... , good clinical practices and institutional policies and procedures. The Senior Clinical Research Monitor mentors and advises less senior… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …advanced solid tumor? We have a role for you! Job Duties: As a Senior Clinical Research Associate, you will monitor clinical trial programs and ... regulations including ICH/GCP and PhRMA guidelines along with Catalyst Clinical Research 's applicable SOPs and working practices....Manager. + Internal support is provided to the Field Monitor from the assigned Clinical Trial Associate.… more
- Pfizer (Pearl River, NY)
- …solves highly complex and specialised problems related to clinical research programs. The clinician medical monitor applies technical/scientific expertise to ... trials by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical...clinical issues. By directing and obtaining consensus from senior staff members, the clinician medical monitor … more
