- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager - Oncology (Remote) This role is primarily accountable for the end-to-end performance and ... ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and ... and sites in a-country.-Under the oversight of the CRA manager or CRD, the person ensures compliance of study-conduct...expands the territory for clinical research , finding and developing new-sites. Participates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Drafts development ... plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL...documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This position supports ... the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This...and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study… more
- Merck & Co. (Rahway, NJ)
- …Provides ongoing clinical database support to other departments. Assist clinical database manager /supervisor in project planning, manpower projections and ... resource allocations across therapy areas. Interface with clinical database manager /supervisor to assure consistency of technical and process strategies across… more
- George Washington University (Washington, DC)
- …and negotiation for all industry supported clinical trials and clinical research . Dedicated Research Program Manager of grant and contract proposals ... graduates across the country. Find out more here: http://smhs.gwu.edu/ The Office of Clinical Research (OCR) in the GW School of Medicine and Health Sciences is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...management systems and archiving systems. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Merck & Co. (Rahway, NJ)
- …Degree in life sciences, preferred.Required experience and skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH).Ability to ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Eisai, Inc (NJ)
- …to obtain all applicable source materialCollaborate with cross functional teams like Clinical Research , Biostatistics, Statistical programming, Clin Ops. etc. to ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... Experience Qualifications1 or More Years with BS. preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical company, a… 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 ... data-driven data quality. This position requires working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications,… more
- Daiichi Sankyo, Inc. (Atlanta, GA)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology ... Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology...hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence… 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 Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting… 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 purpose of ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… 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 ... including the Quality Management System, manufacturing, quality control, warehouse, and clinical operations. The position will provide end users guidance and support… 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 ... business development goals through the successful negotiation and execution of research and strategic partnership contracting agreements. In collaboration with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads ... address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …include research and development, health economics and outcomes research , clinical development, marketing, biostats, corporate communications, and medical ... 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… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol… more
