- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end ... and procedures, quality standards and adverse event reporting-requirements internally and externally.The Clinical Research Manager (CRM) could be responsible… 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 the person ensures compliance of study conduct with-ICH/GCP...expands the territory for clinical research , finding and developing new-sites.-Participates in… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
- Merck & Co. (Rahway, NJ)
- …for our organization, comprising of Process Research & Development, Analytical Research & Development, and Pharmaceutical Sciences & Clinical Supply. The ... their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our...the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... healthcare through research and innovation. Through clinical trials and...initiation, interim and close out visitsExperience as a CRA Manager , Lead CRA or Project ManagerRare disease experienceNOTICE FOR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Merck & Co. (North Wales, PA)
- …and Skills:Required:Three or more years of work experience within clinical /observational research or equivalent-Excellent communication and interpersonal skills; ... to drive and innovate world class Medical & Value Capabilities to advance research and scientific exchange, improving access and health outcomes for patients. 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 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 Position manages ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… 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 Provide support ... for all aspects of Global Clinical Operations with a high degree of quality in...and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food… 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 ... with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to...More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical… 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. SummaryThis 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. (North Wales, PA)
- …for managing any study specific partners and/or vendors.Core SkillsSolid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to ... SummaryThis 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
- 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 ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on ... or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...for NACD & Novo Nordisk (eg, Health Systems, Contract Research Organizations & Site Management Organizations etc.) Manages relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... living. Are you ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of Novo Nordisk Inc.… 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)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummarySupport the PVQA ... interventional, non-interventional, investigator-initiated trials, Managed Access programs and Collaborative Research to the highest quality standards globally end-to-end end… more
