- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...in accordance with DS standards. Act as the project manager of the clinical study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... regulatory agency sponsor inspection with the goal to ensure GCO/ clinical teams are prepared and trained and study...GCO/ clinical teams are prepared and trained and study documentation is quality controlled and available, and all… 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...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- … study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... packages.Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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
- J&J Family of Companies (Raritan, NJ)
- Manager , Clinical Project Manager , Immunology - 2406191544W **Description** Johnson & Johnson is recruiting for a Manager , Clinical Project ... potential. At Johnson & Johnson, we all belong. The Manager , Clinical Trial Leader Project Management (CTPM)...issues for the trial through active management of the study schedule. They enable decision making by developing scenarios… more
- Terumo Medical Corporation (Somerset, NJ)
- Professional and Clinical Training Manager Date: Jun 6, 2024 Req ID: 3138 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: TIS ... Products. **Job Summary** In this fast paced and critical role, Professional and Clinical Training Manager will evaluate and develop training for all associates,… more
- Actalent (Morristown, NJ)
- …Oversees and drives projects from concept to final deliverables in form of publications, clinical study reports, final reports to funding agency, etc. + Acts as ... Job Title: Clinical Research Manager We have openings...Oversees reports and assists with statistical analysis. + Assists study team in the preparation of all audits performed… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...in accordance with DS standards. Act as the project manager of the clinical study … more
- Bausch Health (Bridgewater, NJ)
- …to clinical studies and regulatory submissions. * Represent the clinical pharmacology function in multi-disciplinary study teams including CROs. * Draft ... with our health care products. JOB DESCRIPTION + The clinical pharmacology manager will support the design,...and review relevant clinical pharmacology sections in 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Scientist 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
