- 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
- Bristol Myers Squibb (Summit, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. + Successfully leads, plans, and executes ... + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations . + Proficient knowledge and skills to support program… more
- Bristol Myers Squibb (Madison, NJ)
- …projects + Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects + ... their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …phase 4 and registry studies, working with other internal stakeholders including clinical operations , statistics and regulatory. + Provides scientific and ... scientific and medical activities with other internal stakeholders (ie, commercial, clinical operations , statistics, regulatory, etc.) as they relate to… more
- Bristol Myers Squibb (Madison, NJ)
- …Requirements** + Expertise in GCP/ICH, drug development process, study design, statistics, clinical operations + Recognized internally and externally as a ... progress reports and risk assessment updates to Sr. Management + Reviews and approves clinical contributions to all trial documents / abstracts / publications +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …TA Operations leadership + Identify and implement opportunities for innovation within clinical trial operations and identifies trends or competitors in ... one of more therapeutic areas in Clinical Trial Management (CTM). The Executive Director TA Operations...impose undue hardship on the operation of the Company's business . For roles in which the hired candidate will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Master's Degree preferred **Experience:** + Minimum of 5 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry required. + ... 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
- Sanofi Group (Bridgewater, NJ)
- …project strategy, its endorsement by governance and its execution in close collaboration with clinical operations . The CRD is expected to advance scientific and ... with the global project team and internal partners such as clinical operations , translational medicine, regulatory affairs, biostatistics, drug discovery,… more
- Bristol Myers Squibb (Madison, NJ)
- …Business Process Owners (eg Biostatistics, Regulatory, Clinical Development, Safety and Clinical Trial operations ). This position will be critical to ... **Position Summary** Support the design and deployment of the Business Process Management program to manage and optimize key...(six sigma training is a plus); within Drug Development ( Clinical Development, Trial Operations , Biostatistics,… more
- Bristol Myers Squibb (Madison, NJ)
- …Evidence Generation, finance, development teams, corporate giving, advocacy, professional societies, business operations ) to support One BMS, prioritization and ... and innovation across a matrix. + Experience with drug development, commercialization, healthcare, clinical trial management a plus. If you come across a role… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Bristol Myers Squibb (Summit, NJ)
- …overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites. **Key Responsibilities** + Design , develop ... the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for- cause… more
- Axtria, Inc. (Berkeley Heights, NJ)
- …(eg, personalized marketing), medical affairs (eg, scientific content generation), and clinical operations (eg, trial recruitment) for pharmaceutical ... with team to commercialize GenAI applications for commercial, medical affairs, and clinical operations , securing engagements with large pharma clients. + Ensure… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …agreement requests and support for Manufacturing and Supply Chain, R&D, Clinical Operations , Regulatory, Corporate Procurement, Facilities and Administrative ... The Sr Director, Corporate Counsel - Corporate & Commercial Operations is an integral member of the legal team...to review of sales and promotional materials. + Handle clinical trial and REMS contracting + Supervise… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Bristol Myers Squibb (Madison, NJ)
- …abilities. Medical Review: Provides guidance regarding medical review of individual clinical trial and post-marketing reports. Oversees single case processing ... development and marketed products. Represents MR in the PV Operations and Systems Leadership Team and the WWPS Extended...combined relevant experience, including at least 2 years in clinical practice or relevant setting and at least 5… more
- Bristol Myers Squibb (Madison, NJ)
- …development / management + Pharma R&D experience, preferably Clin Dev't, Trial Operations , Biostatistics, Regulatory, Safety, etc + Transformational change ... (DD) Innovation strategy in partnership with DD Leaders, Process Council, and Business Insights & Technology (BIT) partners. This role will support our DD… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …during the review process. + Actively manage projects through all phases of clinical trial research and commercialization, ensuring timely completion of tasks ... leadership to support new product development (NPD) programs for our global business unit portfolio. This role involves providing regulatory guidance and support… more