- Merck & Co. (Rahway, NJ)
- … supply chain across the full of our company's Research Laboratories portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... development teams and the operational/executional arms within the business .-- - - Working independently, the Protocol Clinical...at clinical development related meetings (i .e., Clinical Trial Team s ) and product… more
- Merck & Co. (Rahway, NJ)
- … supply chain across the full our Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... between clinical development teams and the operational/executional arms within the business .-- - - The Program Clinical Supplies Project Manager (Program… more
- Merck & Co. (Rahway, NJ)
- …matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations , regulatory affairs, and physicians to implement assays and ... of regulatory guidelines (FDA, EMA) pertaining to biomarker development and clinical trial processes.Project Management:-Proficient project management skills to… more
- Merck & Co. (Rahway, NJ)
- …exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to ... and contribute to resource allocation internally and through management of business operations and outsourcing budgetsProvide functional representation on… more
- Genmab (Plainsboro, NJ)
- …working groups; serve as process owner or Subject Matter Expert (SME) within Clinical Operations .Support training initiatives across Trial Operations ... authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager, Team Manager (GCTM-TM) is...field of oncology is preferredMinimum 2 years' experience as Clinical Operations representative in Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner...is preferred A minimum of 12 years' progressively responsible clinical trial experience with at least 10… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... More Years relevant experience is required with a BSc requiredExperience in clinical operations methods and processes in industry setting requiredExperience… more
- Genmab (Plainsboro, NJ)
- …this role, you will be instrumental in ensuring the timely delivery of high-quality clinical trial supplies for both early- and late-stage clinical trials.As ... Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations in Copenhagen or...internally and externally.Experience working with vendors and CMOs for clinical trial supplies will be an advantage.Solid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requiredMaster's Degree preferred Experience: Minimum of 5 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry required.Expertise ... This position reports to the Associate Director Data Management Operations . Business administration activities within the CDR...This position will also work with members of Data Operations , DM, and Biostatistics, Clinical Study teams,… more
- Genmab (Plainsboro, NJ)
- …you will 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 ... Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior ...highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the… more
- Genmab (Plainsboro, NJ)
- … Trial Leads (GTLs), fostering professional growth.Forecast and manage Clinical Trial Management resources including GTLs, CTMs, and CTAs.Requirements:Strong ... people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we...member of the Compound Development Team (CDT) representing Development Operations .Provide input into the Clinical and Compound… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(phase 3b workshops, Investigator Spon- sored Studies) Evaluation and decision of clinical trial proposals from Regions & Affiliates related to ... KOL's and meetings, Scientific Expert Committee meetings Communication: Transforms the clinical trial data into scientific and commercial communication Manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(phase 3b workshops, Investigator Spon- sored Studies) Evaluation and decision of clinical trial proposals from Regions & Affiliates related to ... KOL's and meetings, Scientific Expert Committee meetings Communication: Transforms the clinical trial data into scientific and commercial communication Manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Genmab (Plainsboro, NJ)
- …role will work closely with other functions and departments, including Medical Affairs, Clinical Development, Clinical Operations , CORE (Center of outcomes ... (GPP, ICMJE), and other guidance related to scientific data communication.Understanding of clinical trial design and execution, statistical methods and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conferences Communication: Works with the Global Medical Director(s) to transform the clinical trial data into scientific and commercial communication Works with ... 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… more
- System One (Parsippany, NJ)
- Clinical Trial Associate Parsippany NJ, 07054 (Onsite 5 days a week until ramp up and then flex on Fridays) Contract position slated through 2025 + Assists the ... day-to-day operational activities and other specific projects as assigned within Clinical Operations , including communications with cross-functional teams and… more
- Bristol Myers Squibb (Summit, NJ)
- …with cross functional partners on process improvement as it relates to Cell Therapy clinical trial execution and operations to achieve operational excellence ... subject matter expert (SME) to build and ensure excellence as it relates to clinical trial product handling and administration. This Individual has a masterful… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process. + Monitor clinical trial performance and quality metrics and share with study team, ... are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad,...is required with a BSc required + Experience in clinical operations methods and processes in industry… more
