- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... performs risk management . Represents functional areas and GDMS on cross-functional trial teams and in other trial -level development forums.Under the guidance… 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
- Merck & Co. (Rahway, NJ)
- …(POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies: ... Monitoring Visits Reports and escalates performance issues and training needs to CRA- Manager and/or functional vendor and internal management as needed.o… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management , the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data...and timely execution and delivery of deliverables at the trial level. Primary activities include, but are not limited… more
- Merck & Co. (Rahway, NJ)
- …is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities ... and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments.… more
- 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)
- …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
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… 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
- 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)
- …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 (Rahway, NJ)
- **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 (Raritan, 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
- Intra-Cellular Therapies, Inc (New York, NY)
- …individual to join our company, in the Clinical Operations Department as a **Clinical Trial Manager /** **Senior Clinical Trial Manager ** who ... vendor performance. + Reviews all operational study plans (project management plan, monitoring plan, communications plan, TMF plan) for...Clinical Operations is required; 2+ years as a Clinical Trial Manager + CNS experience is required… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …recruitment and retention strategy that will enable successful implementation by Clinical Trial Management . This role will continue to collaborate with study ... identification & enrolment support in clinical trials working closely with clinical trial management , CROs and global monitoring. + _Supports the development… more
