- 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
- 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)
- …term experiments to advance clinical development. ResponsibilitiesServe as QCP representative on Clinical studies or take a lead on Clinical pharmacology ... the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take...will support or take the lead on generation of study designs, protocols, reviews and authoring reports and co-authoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...Project Lead is primarily responsible for developing and updating Study Supply Plans, managing various work streams with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies...Plan, Clinical Study Reports).Leads and drives the data review process in… 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)
- …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)
- …quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of interventional, non-interventional, ... Business Unit Strategy globally; promote a quality culture by providing study team support to uphold the ethical conduct of interventional, non-interventional,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contracts. Performs financial reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of sourcing and ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… 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 ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports + Must be able to understand, interpret ... Coordinates review of data listings and preparation of interim/final clinical study reports + Assists in determining...regulations), ICH Guidelines, and GCP governing the conduct of clinical studies + Working knowledge and experience… more
- Astellas Pharma (New York, NY)
- …regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to ... (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up...site managers + Experience working in early development Oncology studies **Benefits:** + Medical, Dental and Vision Insurance +… more
- Mount Sinai Health System (New York, NY)
- …per specifications of the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart and all other databases ... **Job Description** The Clinical Program Manager provides clinical...research program. + Liaison with industry sponsors and CROs. Clinical Research Responsibilities: + Responsible for coordinating study… more
- Mount Sinai Health System (New York, NY)
- …of the Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for ... **Job Description** Under minimal supervision, coordinates the clinical assessments of the study subjects;...genetic tests. 7. Independently obtains informed consent for other clinical studies . 8. Mentors Clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a ... necessary to design and deliver on clinical studies and programs. As a Senior Manager ...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Mount Sinai Health System (New York, NY)
- …service recovery for patients and family members who have concerns and escalates to Clinical Nurse Manager /Assistant Nurse Manager /Nursing Shift Manager ... 1. Performs charge nurse duties as assigned. 2. Coordinates with the Clinical Coordinator/ Clinical Nurse Manager /Assistant Nurse Manager /Nursing… more
- Mount Sinai Health System (New York, NY)
- …service recovery for patients and family members who have concerns and escalates to Clinical Nurse Manager /Assistant Nurse Manager /Nursing Shift Manager ... + Performs charge nurse duties as assigned. + Coordinates with the Clinical Coordinator/ Clinical Nurse Manager /Assistant Nurse Manager /Nursing… more
- Mount Sinai Health System (New York, NY)
- …recovery for patients and family members who have concerns and escalates to Clinical Nurse Manager /Assistant Nurse Manager /Nursing Administrator or Patient ... + Performs charge nurse duties as assigned. + Coordinates with the Clinical Coordinator/ Clinical Nurse Manager /Assistant Nurse Manager /Nursing… more
- Pfizer (New York, NY)
- … Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs. In collaboration ... Development and Life Cycle plans. Data generated by epidemiological studies is critical evidence needed to support clinical...informed consent documents and supports the preparation of other clinical study documents as needed. + Data… more
