- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position Use medical and clinical expertise in design, implementation and monitoring of clinical studies ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...assigned therapeutic area. Relationships Reports to the Executive Director- Clinical Research & Development. Internal relationships include working with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development. Experience:Must have at least 5 years' experience in fit-for-purpose clinical biomarker assay development, validation, and implementation in support ... the timely execution of biomarker tests on samples from clinical trials and to perform technical and strategic assessment...of multi-site clinical trials. Global implementation experience is highly desirable.Must have experience overseeing the… more
- Merck & Co. (North Wales, PA)
- …functional groups and global pharma teams-Demonstrated experience in the design, implementation , and analysis of clinical trialsStrong interpersonal skills, as ... Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology indications.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Director, Diagnostic Sciences will be responsible for end-to-end process for CDx Implementation in clinical studies. They will ensure that sample testing and ... support CDx regulatory submission or associated drug regulatory submissionsResponsible for implementation of clinical trial assays at Diagnostics Partners,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...team adherence to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... Are you ready to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing … more
- Merck & Co. (Rahway, NJ)
- …in global COA endpoint strategic plans with Early Development Teams, Value & Implementation and Clinical Sub-teams to assure alignment with product franchise ... Principal Scientist has responsibility for supporting or co-leading global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes… more
- Tris Pharma (Monmouth Junction, NJ)
- …Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and continuous improvement of Good Clinical Practices ... Tris has an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title commensurate with… more
- Novo Nordisk Inc. (San Francisco, CA)
- …and community thought-leaders in an assigned territory. The Rare Renal Clinical Account Manager will be principally responsible for driving disease awareness, ... leader in the rare renal marketplace. The Rare Renal Clinical Account Manager (RRCAM) will be responsible for achieving...customer's needs and increase sales by effective execution and implementation of the approved brand and sales strategy for… more
- Eisai, Inc (NJ)
- …development of service provider strategy and outsourcing requirements for Phase I-IV clinical trials (65%): Manages the entire clinical outsourcing lifecycle, ... change orders, and contract closeout. Drives the contracting process between clinical study teams and service providers (initiation, negotiation, execution, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the following is preferred: Market Research, Data & Analytics, Clinical OperationsPharmaceutical industry experience helpful, but not requiredAbility to exert ... with the ability to act as project lead in the development and implementation of projects, processes and programs. Proficiency with Microsoft Office Suite, market… more
- Merck & Co. (Rahway, NJ)
- …the clinical biomarker strategy, you will be accountable for planning, implementation , and execution of clinical biomarker specimen collection, testing and ... provide biomarker project management and operational expertise to support cross-functional clinical teams, ensuring the timely and efficient delivery of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near ... cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, Central &… more
- Merck & Co. (Rahway, NJ)
- …capabilities. Accountable for driving alignment and ensuring consistency in implementation of inspection management processes across GCTO.Contributes to the ... inspection response, tracking of submissions to the Health Authorities, and implementation of CAPA Plan) are handled consistently, professionally and proactively and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …(LBRI), is currently seeking a Research Coordinator to oversee Dr. Mayer's clinical and pre- clinical lab. The successful applicant will work effectively ... within Dr. Mayer's lab for MRN, which requires specialized knowledge in both clinical and preclinical research. The Coordinator contributes to the overall success of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is responsible for providing strategic direction, planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and ... functional cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview… more
- Merck & Co. (North Wales, PA)
- …9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in Computer Science, Statistics, Applied Mathematics, ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required-Experience and Skills: Proven track record for leading… more
