- Merck & Co. (North Wales, PA)
- …plans, preparation of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead . -Leads team for timeline ... innovative medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning,… more
- 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 ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish… more
- Aequor (NJ)
- …local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain Job Description: 100% ... This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development… more
- Merck & Co. (North Wales, PA)
- …capability that focuses on technology/process simplification and innovation to:Improve the Clinical Trial experience for our patients.Improve efficiency of study ... to first site ready.Remove obstacles and enable the Global Clinical Trial Organization to focus on what...members including but not limited to scrum masters, technical lead (s) and development team to manage high-quality product delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , cross-functional QSP MDT ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with ... the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize ... including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, maintenance, and… 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
- Merck & Co. (North Wales, PA)
- …Asset Development Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling ... 2 years experience in pharma or similar industry setting.Required:Must have experience in clinical trial development and execution; clear strategic view on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... including veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical … 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 ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that Payer and KOL reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act as an ambassador to drive ... functions including but not limited to Commercial, Marketing, Medical, & Clinical Development,ResponsibilitiesGlobal Market Access Strategy- Lead the development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the...to achieve the Target Product Profile (TPP)- Development of clinical sections of trial -level regulatory documents (eg,… more
- Axelon Services Corporation (Atlanta, GA)
- …This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development ... studies during phases 1-4. The individual must partner closely with clinical , regulatory, quality and production associates to ensure timely delivery of supplies to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical Trial Material (CTM) and will also ... with the CSO Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites for GMP processing operations.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for… 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
