- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… 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, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall ... and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management/monitoring activities in compliance with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and ... with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical ... preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The GTL… more
- IQVIA (Newark, NJ)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor management ... becomes the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** , you'll play a key role in our clinical operations,… more
- Actalent (Tarrytown, NY)
- …+ 3+ years of experience in Clinical Research supporting Clinical Trial Managers/ Clinical Research Manager on studies + eTMF Experience (Experience ... has great culture and is rapidly growing! Summary: The Clinical Trial Specialist/In-house CRA provides technical and...assignments from the Clinical Study Leader or Clinical Study Associate Manager . This person will… more
- Hackensack Meridian Health (Hackensack, NJ)
- …comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or ... Management Team, this role will be responsible for developing clinical trial and patient flow manuals of...**Responsibilities** A day in the life of a **Project Manager , Clinical Trials** at Hackensack Meridian _Health_… more
- Hackensack Meridian Health (Hackensack, NJ)
- …oversight across all trials. + Provides guidance for HMH investigators on clinical trial development, including guidance on planning, implementation, milestone ... Generates dashboard reporting to stakeholders in monthly/quarterly/annual tracking of all clinical trial revenue generation, receipt and appropriate allocation… more
- Stryker (Mahwah, NJ)
- …Minimum of 4 to maximum of 6 years related work experience required + Related clinical trial associate, clinical study associate, clinical research ... our award-winning organization by visiting stryker.com Stryker is seeking to hire a ** Clinical Study Manager ** to support Joint Replacement Clinical Trials.… more
- Hackensack Meridian Health (Hackensack, NJ)
- … Coordinators, Clinical Data Coordinators, Regulatory staff and other clinical trial support staff, assigns schedules and makes operational decisions ... and serve as a leader of positive change. The Manager , Clinical Research Ops is responsible for...that research related fees are appropriately captured and that trial agreements are fully executed. + Works on special… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists with and may author/review ... The Senior Manager , Hematology, Clinical Scientist leads in...process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements. Considerable organizational awareness,… more
