- Bristol Myers Squibb (Summit, NJ)
- …with demonstrated progression clinical pharmacology and Pharmacometrics experience + For Sr . Research Investigator , with Ph.D. approximately 2+ years ... with demonstrated progression clinical pharmacology and Pharmacometrics + For Research Investigator , with Ph.D. approximately 0-2 years experience with… more
- Hackensack Meridian Health (Hackensack, NJ)
- …regulatory issues and changes within the protocol. + In collaboration with the principal investigator , clinical research coordinator, and clinical team, ... prior to submitting study. + Reviews study with principal investigator and/or clinical research nurses...field. + Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior… more
- Hackensack Meridian Health (Hackensack, NJ)
- …regulatory issues and changes within the protocol. + In collaboration with the principal investigator , clinical research coordinator, and clinical team, ... prior to submitting study. + Reviews study with principal investigator and/or clinical research nurses...field. + Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior… more
- Amgen (Newark, NJ)
- …sponsored research and respond to requests for investigator sponsored research proposals. + Provide clinical and economic value information to payers and ... solid tumor portfolio, primarily focused on thoracic malignancies. The Sr . MSL is an integral position in assuring accurate,...related field, including 1 or more years focused on clinical practice, clinical research , or… more
- Actalent (Morristown, NJ)
- Job Description The Senior Clinical Trial Associate ( Sr . CTA) is responsible for supporting the daily workflow of clinical operations activities. The ... up a TMF is helpful. Essential Skills + Working knowledge of ICH/GCP and clinical research processes. + Solid working knowledge and experience utilizing an eTMF… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …trials, across all therapeutic areas, around the world. In partnership with Clinical Research , Medical Affairs and Development Operations functions, ensures that ... field with 4+ years of trial management experience **PREFERRED:** + Extensive clinical research knowledge and cross-functional understanding of clinical … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Senior Clinical Research Associate (CRA) will act as a liaison between BD (the study Sponsor) and the sites/clinics that ... Investigator and their staff at their assigned clinical study sites. The Senior CRA will...well as hernia repair mesh and fixation systems. The Senior Clinical Research Associate (CRA)… more
- Vitalief (Livingston, NJ)
- … Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, ... + Strong understanding and knowledge base of coordination requirements associated with clinical research trials. + Ability to interface effectively with all… more
- IQVIA (Parsippany, NJ)
- …in lieu of degree. * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, ie, Good Clinical Practice (GCP) and ... the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with...and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and management of several clinical programs worldwide across all phases of clinical research . The individual will oversee study teams and will be responsible ... Senior Director Clinical Development - Respiratory...able to function independently in the daily management of clinical research projects including the preparation/review of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership ... The ** Senior Manager Clinical Study Lead** (CSL)...study + Oversees/conducts site evaluation and selection + Leads investigator meeting preparation and execution + Monitors progress for… more
- Bristol Myers Squibb (Summit, NJ)
- …scientific field preferred) . **Experience Requirements** + 5+ years of experience in clinical science, clinical research , or equivalent. + Proficient ... more: careers.bms.com/working-with-us . **Functional Area Description** The Early Development Clinical Scientist function provides scientific expertise necessary to design… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research , Medical Affairs and Development functions, ensures that all ... relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports + Must be able… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Support Fair Market Value process in evaluating study budgets Collect ... More Years with Bachelor of Science required - Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. **Summary** The Senior Director sits within Global Oncology Clinical Development, an organization ... which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM): + Provides oversight...+ May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section… more
- Bristol Myers Squibb (Madison, NJ)
- …in close partnership with the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory, Translational Development, and Market ... quality, timeliness, and budget. + Responsible for the evaluation and support of investigator -initiated trials. + Provide high quality clinical input and review… more
- Bristol Myers Squibb (Summit, NJ)
- …and Abilities + Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance + ... conduct and reporting of internal and external audits of clinical trial investigator sites. **Key Responsibilities** +...Very experienced in nonclinical/ clinical research /pharmacovigilance experience + In-depth knowledge of… more
- Sanofi Group (Morristown, NJ)
- …guidance and serving as the key liaison between global Medical, the Principal Investigator (PI), and the US Medical Team on Sanofi-sponsored studies, as delegated by ... Identify, establish, build, grow, and maintain strategic relationships with senior experts, key opinion leaders (KOLs), professional societies, immunization advisory… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator 's brochures, CTD summaries/overviews, ... timelines and resource planning for assigned projects. + May serve as a senior medical writer and department representative for a large development program or TA,… more