- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. We are currently seeking a Clinical Trial Business Operations Intern for the summer of ... in data management or related field. Prior experience in a corporate business environment is preferred; experience in the pharmaceutical industry is a plus.… more
- Novo Nordisk (Plainsboro, NJ)
- …documentation from draft protocol through trial closure for North America Clinical Operations (NACO) + Manages and communicates financial status of ongoing ... including the NACO senior leadership team and line of business management team, as well as the broader North...skills + Demonstrated core understanding of clinical operations and budgeting with respects to trial … more
- IQVIA (Bridgewater, NJ)
- …This is an important and high-profile role within our Research and Development Clinical Operations organization and IQVIA's size and global footprint will ... The Associate Clinical Project Manager/Local Trial Manager is...2-3 years prior project management experience and experience in clinical operations ; or equivalent combination of education,… 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,...accurate for assigned stud(ies). + If assigned, Associate Director, Clinical Operations may act as the Study… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills to ... in lieu of relevant experience. Direct experience managing global clinical trial operations is a...impose undue hardship on the operation of the Company's business . For roles in which the hired candidate will… more
- Bristol Myers Squibb (Princeton, NJ)
- …programs. + Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the ... studies within assigned area + May serve as a Clinical Trial Lead or Co-Lead as needed...knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Ability to plan and… more
- AbbVie (Branchburg, NJ)
- …coordinates appropriate scientific activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory, etc.) as they ... expertise for the strategy. Once completed, in collaboration with clinical operations , is responsible for and leads...key contact for the Integrated Evidence Strategy Team, and Clinical Trial Team(s) regarding the scientific/ clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …clinical studies and programs. This position involves leading and executing clinical trial activities, collaborating with cross-functional teams, and liaising ... Will be responsible for design and execution of assigned clinical trial activities and work closely with...knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Ability to understand assigned… more
- Bristol Myers Squibb (Princeton, 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 (Princeton, NJ)
- …projects + Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects + ... Join us and make a difference. The Senior Manager, Clinical Data Management (Data Management Lead) is a role...Data Management and Centralized Monitoring function of Global Development Operations (GDO). This is an office-based position at BMS… more
- Vitalief (New Brunswick, NJ)
- …of the research and clinical trials environment through optimizing existing business operations , and continually improving the success of our client's ... partner focused on improving the value and contribution of clinical trial sites across the drug development...+ 10 or more years of combined consulting and clinical research operations experience, successfully delivering innovative… 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
- Sanofi Group (Bridgewater, NJ)
- …sites. + Provide transversal collaboration by supporting early planning activities, optimizing clinical trial operations , improving site engagement, and ... Study Unit (CSU) is the site facing arm of clinical operations that is responsible for monitoring...are our experts with deep knowledge and know-how of clinical trial delivery in our key strategic… more
- Novo Nordisk (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...preferred + A minimum of 12 years' progressively responsible clinical trial experience with at least 10… more
- System One (Princeton, NJ)
- …cost per patient budgets and site contracts for North America (US and Canada) Clinical Operations . + Coordinates with Trial Managers to plan site ... for tracking and trending and reports to Manager of Clinical Finance and Operations , and Trial...Trial Managers. + Independently researches complex legal and business issues in support of budget determination and negotiation,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Exchange, and Dashboards.And in the R&D space including but not limited to clinical trial management system, drug labeling, and learning management system. + ... as secondary point of contact of R&D areas including but not limited to clinical trial management system, drug labeling, and learning management system. +… more
- Penn Medicine (Plainsboro, NJ)
- …the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to ... this leading academic medical center means collaboration with top clinical , technical and business professionals across all...to develop project plans and support day to day operations of clinical research proposals for their… more
- Hackensack Meridian Health (Edison, NJ)
- …+ Maintains accurate, complete, up-to-date records on each patient participating in a clinical trial protocol in all applicable systems (ie electronic medical ... Research Nurse is responsible for coordinating and overseeing clinical research operations for all assigned ...record, clinical trial management system, departmental and protocol… more
- Novo Nordisk (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- ... Safety Surveillance and other cross functional teams. Oversees daily operations of the function by directing staff and adhering...+ Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Bristol Myers Squibb (Princeton, NJ)
- …Provide statistical input into other relevant functional groups' activities (including clinical development, clinical operations , regulatory, medical ... issues to senior executives and enable decision-making + Extensive knowledge of clinical trial development and statistical methodology related to trial … more