- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study Strategy: Drafts development plan under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of standard hierarchy structures and user access controls for all clinical studies . This position may have direct reports and/or dedicated ... around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a...work with members of Data Operations, DM, and Biostatistics, Clinical Study teams, IT/Information Services and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This position ... is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is...supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work streams with key… more
- Merck & Co. (Rahway, NJ)
- …'end-to-end' integrated clinical supply chain across the full of our company's Research Laboratories portfolio of clinical trial s .- GCS is accountable for ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM)...- Responsible and accountable for establishing the timelines for clinical supply needs per study and providing… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our Research & Development ... teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... financial reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of...to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager , Team Manager (GCTM-TM) is responsible for line ... and strategic support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... clinical activities beyond phase 3a (phase 3b workshops, Investigator Spon- sored Studies ) Evaluation and decision of clinical trial proposals from Regions &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …direct implications for account team planning and implementation. Entails coordinating market research and development of access and ARP scenarios to ensure launch ... scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making Assesses investments in payer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... MD, DO, PhD, or PharmD required A minimum of 5 years of combined clinical , research or Pharma experience required Experience in relevant therapeutic area… more
- Mount Sinai Health System (New York, NY)
- …Activities of Ongoing Clinical Trials** + Assist in the activities related to clinical research studies including but not limited to answering phone ... safeguarding of patients' rights in research **Manage Study Data of Ongoing Clinical Trials Under...and specimen handling + Under the supervision of the clinical research manager , the coordinator… more
- Mount Sinai Health System (New York, NY)
- …the Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for ... clinical research data. 2. Coordinates the clinical assessments of the study subjects including...Independently obtains informed consent for other clinical studies . 8. Mentors Clinical Research … more
- Mount Sinai Health System (New York, NY)
- …The Center for Psychedelic Therapy Research is looking for a full-time clinical research project manager in a high-profile, cutting-edge clinical ... manager will create and execute plans for complex research projects that may include clinical trials and biological studies of PTSD. This position… more
- Mount Sinai Health System (New York, NY)
- …CRSU office (including pre-award, post award and QAP). ** Clinical Research Responsibilities:** + Responsible for coordinating study enrollment, establishing ... and assist in the administration and plan of the research program. The Clinical Program Manager...the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart… more
- Meta (New York, NY)
- …Health and Wellbeing team is seeking a highly experienced clinical study manager to support clinical research operations. The Clinical Study ... device research . 8. Demonstrated track record of clinical study operational execution, participation in ... research organizations, and with virtual or remote clinical studies . 13. Experience with multi-center … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is… more
- American Heart Association (New York, NY)
- …impact you can make with us. The American Heart Association has an opportunity for ** Clinical Studies Implementation Manager ** . This position can be home ... day-to-day site recruitment, site consultation, and project management of activities for clinical studies . This person will identify, build, nurture, and… more
