- Merck & Co. (Rahway, NJ)
- …with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...engagements. This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and… more
- 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...abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Merck & Co. (Rahway, NJ)
- …testing new systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, ... we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating...your role will be to collaborate with members of study teams, including external CROs/Vendors, to incorporate study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... the global clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and reporting on … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, ... for performing near real-time biosample tracking for the assigned studies in close collaboration with the QCP, Clinical...QCP, Clinical Biomarker Team, Companion Diagnostics, the Clinical Study Teams, Central & Specialty Laboratories,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …conduct of Interventional, Non-interventional, Managed Access Programs, Investigator initiated studies and Collaborative Research .Support adherence to regulatory ... studies , Compassionate Use or Managed Access Programs, Investigator initiated studies and Collaborative Research to include timely escalation of Quality… 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)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… 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
- 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 Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, Labor… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT… 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 NOTE: This ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as… 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
- HSS (New York, NY)
- …our Mission, you too can be part of our transformation across the enterprise. Clinical Research Manager - Industry Full-Time Summary: This position ... but not limited to thematic area, industry, and pharmaceutical studies . The Research Manager facilitates...needed patient renumeration and reporting of expense reports to study lead/director. + The Research Manager… more
- Vitalief (Newark, NJ)
- …transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Clinical Research Study Manager to join our exceptional team ... Work Location: Newark, NJ Responsibilities: + Reporting to the Director of Clinical Research Operations, provide support, establish workflows and processes to… more
- Colgate-Palmolive (Piscataway, NJ)
- …health-related behaviors. The ideal candidate will have a proven track record of conducting clinical research studies , with a focus on conducting oral health ... **Key Responsibilities** + Lead the planning and execution of clinical research studies from conception...studies from conception through to publication. + Develop research protocols, informed consent forms, and other study… more
- The Mount Sinai Health System (New York, NY)
- …Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects. + ... **JOB DESCRIPTION** Under minimal supervision, coordinates the clinical assessments of the study subjects;...Independently obtains informed consent for other clinical studies . + Mentors Clinical Research … more
- IQVIA (Parsippany, NJ)
- **Job Overview** Join our team as a Clinical Research Site Manager , where you'll play a crucial role in ensuring our study sites operate seamlessly and ... with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the… more
- The 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
