- Actalent (Princeton, NJ)
- …Master File (TMF) filing. + Evaluate regulatory packages and manage documents within the Clinical Trial Management System (CTMS). + Supervise study start-up ... Job Title: Clinical Trial ManagerJob Description The ...of study materials and investigational product by liaising with Clinical Supply Chain or external service providers.… more
- Bristol Myers Squibb (Princeton, NJ)
- …pilots or new methods that keep the organization at the forefront of clinical trial innovation with a consultative mindset and approach **Cross-Functional ... **advanced analytics** (eg, forecasting, modeling, AI/ML) and strong understanding of clinical trial processes (feasibility, site selection, patient enrollment).… more
- Sumitomo Pharma (Trenton, NJ)
- …staff as required. **Key** **Core** **Competencies** + Demonstrate experience with clinical supply management planning, packaging, labeling, distribution ... use of commercial products used in clinical trial . + Manage clinical supply ...and logistics. + Clinical Supply management experience using CMO strongly preferred.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …_Experience Qualifications:_ + 7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical ... Supply Plans in close communication with CSO project Management Lead. + Responsible for the Clinical ... Planning as requested. + Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents. + Supports… more
- J&J Family of Companies (Titusville, NJ)
- …used in clinical supply chain, eg, forecasting (4C), Randomization & Trial Supply Management systems (multiple RTSM vendors), SAP, E2E planning ... at https://www.jnj.com/innovative-medicine **We are searching for the** **best talent for** **Manager, Clinical Supply Chain Data** **to be in** **Titusville, NJ… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... of medical accountability and oversight for one or more clinical trials + Matrix management responsibilities across...achieve the Target Product Profile (TPP) + Development of clinical sections of trial -level regulatory documents (eg,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …_Experience Qualifications_ + 7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical ... management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The...Logistics (SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Merck (Rahway, NJ)
- …Clinical Supplies Management , Clinical Supply Chain Management , Clinical Trial Protocols, Cross-Functional Communications, Data Management ... **Job Description** **Summary:** Global Clinical Supply (GCS) Operations is seeking...Global Operations Management , GMP Compliance, Inventory Control Management , Logistics Coordination, Management Process, Manufacturing Compliance,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management . required - 4+ years combined ... and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle. - Applies GCP principles to ensure all laboratory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting ... data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disease preferred - 7 or more years of working knowledge of Clinical trial data systems and/or EDC lab management tools is a preferred Daiichi Sankyo, ... expertise to promote and implement best practices across the Clinical Trial lifecycle. Remains current with and...CFR preferred - 7 or more years' experience in clinical data management experience in a medical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …respect to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting. + ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …portfolio performance. + Partner with senior leadership in key R&D functions ( Clinical Management , Data Management , Global Pharmacovigilance, Regulatory ... actuals vs. forecasts in collaboration with Finance and key functional partners ( Clinical Management , Regulatory Affairs, Global Quality, Data Management ,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred + If you have a high attention to detail; ... area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply , lead and/or supervise… more
- Weill Cornell Medical College (New York, NY)
- …the preparation of budgets and other regulatory items for grant submission and clinical trial applications. + Leads and participates in new assay development ... related to the planning, performance and supervision of basic and/or clinical research. **Job Responsibilities** + Develops, implements and enforces policies and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more