- 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 ... or related field. Prior experience in a corporate business environment is preferred ; experience in the pharmaceutical industry is a plus. Daiichi Sankyo, Inc.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development, validation, or implementation Experience with medical product development and trial design is preferred Demonstrated ability in generating patient ... economics, statistics or decision sciences, psychometrics, or similar is preferred . Related experience: preferably pharmaceutical industry or consulting experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in ... compliance. Proactively track, monitor and report trial risks, progress/performance, timelines, and financial metrics on an ongoing basis to study and program teams.… 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 ... to achieve the Target Product Profile (TPP)Development of clinical sections of trial -level regulatory documents (eg, response to HAs, briefing book, etc.) in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical ... clinical data to ensure quality, completeness, and integrity of trial conduct.Providing tactical/scientific mentorship to other clinical scientist.Core Skills Solid… more
- Merck & Co. (Rahway, NJ)
- …field plus 9 years SAS/R programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS/R programming experience in a clinical trial environmentRequired Experience and Skills: Excellent interpersonal skills and ability to… more
- Aequor (South San Francisco, CA)
- …is to optimize the support of clinical systems to provide high-quality clinical trial data insights and to offer data science-related consultation to the study ... Life Sciences, Public Health, or a related field. Master's degree preferred . 5&plus years experience in Biotech/Pharmaceutical industry with knowledge of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Data Management coding documentation and approval/signatures forms in the TMF ( Trial Master File) on an ongoing basis according to applicable Daiichi Sankyo ... Degree requiredCoding Certification - Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience… more
- Merck & Co. (Rahway, NJ)
- …chain across the full of our Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging and ... s as the GCS spokesperson at clinical development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have… more
- Merck & Co. (Rahway, NJ)
- …platformTransform the way we conduct our clinical trials.Improve the clinical trial experience for our patients.Improve efficiency, reduce cycle time and enable ... Management supporting Information Technology, or Pharmaceutical Research or Clinical Trial Operations or Business Management3+ Experience working with agile… more
- Merck & Co. (Rahway, NJ)
- …have a medical contact within the company.Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of ... the level of interest and qualifications for a specific compound or trial .Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical… more
- Merck & Co. (North Wales, PA)
- …and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field and at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal skills and ability to negotiate and… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor ... information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review… more
- Merck & Co. (St. Louis, MO)
- …Studies Program (OTSP)-research studies.-Upon request from Global Clinical Trial Operations (GCTO):-Identify barriers to patient enrollment and retention ... scientific merit, and qualifications for a specific compound or trial --Scientific Congresses:-Engage-in-scientific and medical meetings through pre-congress preparation, facilitate… more
- Insmed Incorporated (Chicago, IL)
- …Clinical Operations, and Medical Affairs Departments. This may include trial site identification, ongoing recruitment motivation, and issue/problem solvingProvide ... experienceOther Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/ trial experience and 2 years clinical or research experience… 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 ... guidelines governing clinical trials preferredUnderstanding and experience with end-to-end clinical trial processes and functions including experience in one or more… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and Canada as well ... development, effective execution of CMR role-specific/technical training (eg clinical trial -related, patient safety, therapeutic area leads, MSLs etc.) across the… more
- Insmed Incorporated (San Diego, CA)
- …including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and ... a cross-functional team.Supporting or preparing data interpretation and clinical trial reports.Preparing Investigator Alert letters and SAE reports in collaboration… more
