- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Legal. Essential Functions Leads the coordination and preparation of RE/AB budget support and documentation from draft protocol through trial closure for ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Clinical Trial Business Operations Intern for the summer of 2025. This full time position ... CTBO Analyst Intern: Assist in providing operational and analytical support to the CTBO team Help in the collection,...in the collection, organization, and analysis of data to support various projects Utilize data to identify trends, patterns,… more
- Genmab (Plainsboro, NJ)
- …Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project/ Trial ManagementObtain Project/ Trial specific information to initiate drug supply ... scenarios) that may impact clinical drug supply)Create and maintain program/project and trial IMP/AMP forecast and demand plans throughout the trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and site identification activities in collaboration with the CRO ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a ... (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical… more
- Genmab (Plainsboro, NJ)
- …trial drug supply.Maintain agreements, contracts, and SOPs to support efficient operations.Forecast demand, manage inventory, and prevent stockouts.Lead ... an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a natural part… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes...least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics,… more
- Genmab (Plainsboro, NJ)
- …indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director ... in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication… more
- Genmab (Plainsboro, NJ)
- …play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials. In addition, this position offers ... a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical Drug Supply Planning team.… more
- Genmab (Plainsboro, NJ)
- …collaborate with a diverse group of internal and external stakeholders (eg Scientists, Trial Managers, Data Managers, Clinicians, vendors) to support the overall ... sourcing for new trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial... trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview of ... to ensure SOP updates are coordinated across functions and/or initiatives to support timely implementation while minimizing change. Identify, escalate, and plan and… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes...plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with ... activities (MedDRA and WHO Drug Coding dictionaries) including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development,… more
- Insmed Incorporated (New York, NY)
- …external healthcare practitioners to provide comprehensive medical and scientific support for Insmed assigned therapeutic areas. Engages appropriately in scientific ... and scientific information on Insmed therapeutic disease areas and/or product support of appropriate prescribing, improved patient outcomes.Present data on Insmed… more
- Merck & Co. (Rahway, NJ)
- …Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team; Biostats, ... efficient implementation.-Incorporate cutting edge scientific and technical advances to support clinical developments. Proactively identify and engage external KOL's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and Canada...etc.) across the US and Canada as well as support the CMR/non-CMR activities in Mexico City GBS and… more
- Merck & Co. (St. Louis, MO)
- …of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support , and Scientific Insights.RMSDs liaise between the scientific community and the ... Translational Studies Program (OTSP)-research studies.-Upon request from Global Clinical Trial Operations (GCTO):-Identify barriers to patient enrollment and retention… more
- Genmab (NJ)
- …planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end ... for development of Clinical OperationsEnsures data management activities and processes support the efficient and effective execution of clinical trials.Ensures … more
- Merck & Co. (North Wales, PA)
- …Regional Director of Medical Affairs (RDMA) (where applicable), US Global Clinical Trial Organization, Global Medical and Scientific Affairs (GMSA) TA leads, and ... Director of Scientific Affairs (EDSA), providing our Company's Investigator Studies Program support for assigned TA that may include Areas of Interest (AOI)… more
