- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety related to managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems. ... Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships...start up through closure, including but not limited to: Management of clinical trial documents, including but… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provide input to process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and highest quality ... and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance or… more
- Tris Pharma (Monmouth Junction, NJ)
- …vendors performing clinical study work May also function as a Clinical Trial Manager (CTM), as neededRequirementsSpecial knowledge or skills needed and/or ... science related field and minimum 10 years Clinical Operations and/or Clinical Trial Management experience in a pharmaceutical, biotechnology, clinical research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance or feedback to ... and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as...complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; ... with commercial group regarding new indications for Life Cycle Management .Additional non-study related activities: Clinical Development involvement in due diligence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs ... deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission ... Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business areas.ResponsibilitiesFacilitate the implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access ... with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and comparators to support optimal… more
- Merck (West Point, PA)
- **Job Description** The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a ... management . Represents functional areas and GDMS on cross-functional trial teams and in other trial -level development...data, and clinical outcomes assessments. 2. Serves as project manager of all clinical data management activities… more
- J&J Family of Companies (Trenton, NJ)
- …can be located remotely within the United States. The Senior Local Trial Manager (Sr. LTM) is responsible for local management of a clinical trial ... LTM I roles. The Senior Local Trial Manager (Sr. LTM) may have some site management...some site management responsibilities. The Senior Local Trial Manager (Sr. LTM) may also perform… more
- Merck (Trenton, NJ)
- **Job Description** **Position Description:** **Supplier Manager ** The Supplier Manager key responsibility is to provide strategic program level cross supplier ... management and oversight for programs identified as critical to...identified as critical to the success of Global Clinical Trial Operations (GCTO), Global Clinical Development (GCD) objectives and… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as an integral member ... team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis Oncology… more
- Bristol Myers Squibb (Trenton, NJ)
- …+ Collaborates with the TA Medical Lead, CTL, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study protocol and ICF, ... particularly related to medical monitoring-related activities. + Partners with CTL and global Trial Manager (GTM) to support executional delivery of studies (eg,… more
- Bristol Myers Squibb (Princeton, NJ)
- …in BMS clinical trials. Will serve as a key member of clinical trial teams, partnering with various internal and external stakeholders to support, raise awareness ... trials in a variety of indications to drive and accelerate clinical trial recruitment for BMS. **Key Responsibilities** + Responsible for building and implementing… more
- J&J Family of Companies (Horsham, PA)
- …of results; preparation of oral and written internal/external presentations; development, management , and tracking of trial budgets; and budget and ... Manager , Clinical Project Scientist - 2406183870W **Description** Johnson...experience; including a minimum of two years in clinical trial project management /operations experience working in Clinical… more
- Merck (Trenton, NJ)
- …is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities ... country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). + Oversees and tracks clinical research-related… more
- Bristol Myers Squibb (Trenton, NJ)
- …enact best practices with instruction + Provide regular and timely updates to manager / management as requested + Develop Protocol and ICF documents / amendments ... Objective + Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned… more
