- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders communicating ... is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the...management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key… more
- Merck & Co. (Rahway, NJ)
- …standards.It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with ... In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (ie use of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... assessment.Collaborates with global stakeholders from EIT and leaders across regions in Compliance , Ethics, Risk Management, Legal, Data Privacy, and Information… more
- Centria Autism (Winston Salem, NC)
- …Summary As a leader in Centria Autism's Applied Behavior Analysis (ABA) organization, the Director of Clinical Services will play a pivotal role in providing ... and manage the onboarding and training process for new Supervising Clinicians. The Director of Clinical Services' collaboration with the Area Director … more
- Centria Autism (Tempe, AZ)
- …service experience for team members, and a high level of operational and clinical compliance . Success also includes meeting or exceeding personal qualitative and ... journey. See what it's like Position Summary The Area Director of Clinical Services will play a... case support and supervision to their Directors of Clinical Services by assisting with case reviews, data… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applications and best practices as well as strong technical skills in working with ( clinical ) data . The position holder will require strong skills in continuous ... understanding and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination- Identify… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director serves as the subject matter expert for our products and related data within a Therapeutic Are. The Medical Director is a team player, detail ... the drafting of medical/ scientific documents, safety monitoring, and data analyses. The Medical Director will also...abstracts and manuscripts Provide leadership in the execution of clinical trials Ensure compliance with SOPs, ICH,… more
- Centria Autism (Tempe, AZ)
- …service experience for team members, and a high level of operational and clinical compliance . Success also includes meeting or exceeding personal qualitative and ... clients and their families on their journey. The Area Director of Clinical Services will play a... case support and supervision to their Directors of Clinical Services by assisting with case reviews, data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of scientific summaries, abstracts and manuscripts Provide leadership in the execution of clinical trials Ensure compliance with SOPs, ICH, GCP and other ... industry experience, including time managing clinical trials, or academic clinical research background Working knowledge of biostatistics, data management, … more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director , ... Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor and process team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical education, research grants,… more
- Tris Pharma (Monmouth Junction, NJ)
- …reports, periodic benefit risk evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety...with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews… more
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