- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of all issues/ discrepancies.Responsibilities- Proactively seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV ... Life Sciences required Experience Qualifications- 4 or More Years in clinical trial outsourcing , health sciences or related field ( clinical trials) required-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...selection process in collaboration with the study team and outsourcing procurement management.Lead the creation of the CRO scope… more
- Genmab (Plainsboro, NJ)
- …the relationships with the clinical vendors as well as coordinate and manage outsourcing of new trials. The role will include responsibilities in - and is not ... to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, facilitate communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... service providers and working with internal departments to progress clinical supply projects. Every effort has been made to.../ single-day travel will be required to go to outsourcing vendors from time to time infrequently. Daiichi Sankyo,… more
- Merck & Co. (Lower Gwynedd, PA)
- …strategic business planning skills set to join the Translational Sciences and Outsourcing group at West Point/Spring-House, PA to deliver and execute on laboratory ... (absorption, distribution, metabolism and excretion) screening, quantitative measurement and vaccine clinical assays, and is able facilitate the execution of these… more
- Merck & Co. (Rahway, NJ)
- …oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. The position will be heavily ... the quality lead for the oversight platform,Supporting product development teams in outsourcing activities to enable our diverse pipelineServing as the bridge for… more
- Merck & Co. (Rahway, NJ)
- …models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle ... allocation internally and through management of business operations and outsourcing budgetsProvide functional representation on committees, task forces or… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …around piloting of new technologies to implement and support best-in-class clinical outsourcing approach. + Proactively identify potential Clinical ... required, Life Sciences preferred. + 7 or more years in clinical outsourcing , contract management, or procurement in the pharmaceutical industry and/or … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and assist in the development and implementation of the our Global Clinical Category Management strategy by gathering and anticipating business supply needs and ... * Collaborating with partners leading discussions related to the Global Clinical Category strategies and aligns category priorities. * Manages negotiations, supplier… more
- US Tech Solutions (Foster City, CA)
- …skills with counterparts in other functional teams (eg, Biomarker Sciences, **Vendor** ** Outsourcing , Clinical Operations** , and Data Management) to ensure ... **POSITION OVERVIEW:** You will work with and collaborate with ** Clinical Operations, Biomarker Sciences,** Clinical Pharmacology and other cross-functional team… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …issues/ discrepancies. **Responsibilities** - Proactively seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV ... Sciences required **Experience Qualifications** - 4 or More Years in clinical trial outsourcing , health sciences or related field ( clinical trials) required… more
- Bristol Myers Squibb (Princeton, NJ)
- …Operations and Procurement. + Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development ... and be responsible for setting strategy for translational activities including clinical biomarker activities to support drug development programs. This individual… more
- HCA Healthcare (Waycross, GA)
- …one of the nation's leaders in providing progressive, quality care hospital-based clinical outsourcing in the country, serving multiple departments including ... who share and shape best practices. We harness a nationwide collection of tools, clinical resources and knowledge for our hospitalists who provide the best for their… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of the study ... The **Senior Manager Clinical Study Lead** (CSL) is expected to operate...for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of the study ... The **Manager Clinical Study Lead** (CSL **)** may perform the...the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …process development and improvement. + Expert in the planning, analysis and reporting of clinical trials. + Experience working in an outsourcing model (fully or ... Senior Manager Clinical Statistician Date: Feb 14, 2025 Location: Parsippany,...packages, integrated analyses, and regulatory responses. + Collaborates with outsourcing partners and oversees conduct of statistical aspects of… more
- Insight Global (Lower Gwynedd, PA)
- …as validation protocols and validation reports as directed by supervisor, or other clinical personnel. Works with outsourcing team to support transfer of methods ... and document validation samples for use in method validations. Works with outsourcing group to plan and support method cross-validations. Assists in creating and… more
- Amgen (Washington, DC)
- …programs + Experience with biomarker assay development and qualification, analysis of clinical samples, and leading biomarker assay outsourcing processes with ... while transforming your career. **Associate Director, Global Biomarker Lead - Oncology Clinical Biomarkers** **What you will do** Let's do this. Let's change the… more
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