- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …externally) to understand and address barriers to diverse participation in DS clinical trials - Clinical Trial Design- Provide input to Therapeutic area ... around rare diseases and immune disorders.Summary The Head of Clinical Trial (CT) Diversity sits within Global...(KPIs) to analyze and report on diversity metrics in clinical trials - Monitor data and… more
- Merck & Co. (Rahway, NJ)
- …Department of the GCTO organization focuses on the planning, execution and close out of clinical trials within a program.- Clinical trials provide the ... the scientific planning and execution of one or more clinical trials . You will assist the Lead...Prepare clinical narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance and quality metrics and share ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...assess potential risks to the study and propose mitigation plans. Monitor study budget against trial progress and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical...valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are followed.Establish tracking mechanisms at the study team and clinical trial site level to proactively monitor diversity performance and implement ... Voice Strategy and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development (ie. Patient voice)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lessons learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:- monitor GCO processes ... expertise and trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …build 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study ... degree with minimum of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance. required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leading and managing one or more clinical scientists, oversee a program of clinical trials from the clinical science perspective, and ensure the writing ... of high quality clinical trial protocols, review of ...results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge,… more
- Tris Pharma (Monmouth Junction, NJ)
- …and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and ... medical understanding of safety and efficacy resultsActs as Medical Monitor for one or more studies, as neededCollaborates with...by working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Serves as a primary source of medical accountability ... and oversight for one or more clinical trials Matrix management responsibilities across the...input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …value of assets and the enterprise as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across ... launch) Commercial Strategic Input: Provide strategic input into early-stage pipeline clinical trial activities ensuring alignment with regulatory requirements… more
- Catalent (Philadelphia, PA)
- …and improvement.Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to good manufacturing ... reading of written documents and frequent use of computer monitor . Why you should join Catalent: Defined career path...sizes to advance new medicines from early development to clinical trials and to the market. Catalent… more
- Catalent (Philadelphia, PA)
- …and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials , as applicable. Writes and approves Quality unit SOPs ... Philadelphia, PAPosition Summary: The Quality function is to build, monitor , and sustain a robust and effective quality system...15 + years of Scientific or Quality Assurance in clinical trials packaging, in addition of commercial… more
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