- Formation Bio (New York, NY)
- …multi-center clinical trials. In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines. Strong strategic thinking and ... or a related field. Minimum of 10 years of clinical project management/ clinical operations experience,...a sponsor company. Experience in the integrated in house clinical trial execution model. Experience working with… more
- Merck & Co. (Rahway, NJ)
- …and Trade, Distribution, Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and ... Job DescriptionThe Global Clinical Supply (GCS) organization is...but are not limited to: - Participates on the Clinical Trial Team (CTT) and collaborates closely… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in ... defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site...site personnel and investigators. Competencies + Phase 1 study operations + ICH/GCP + Clinical research +… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Clinical Trial Business Operations Intern for Summer 2026. This ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...you will provide operational and analytical support to the Clinical Trial Business Operations (CTBO)… more
- Aequor (Basking Ridge, NJ)
- …or returned drug supply as well as experience managing third-party contract clinical supply operations required Global experience required (member ... knowledge of blinding approaches and technologies to support various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a minimum of 7 years relevant experience required- Experience Qualifications- Experience in global clinical operations methods and processes in industry ... study team in end-to end delivery of the clinical trial with consistency, quality and per...or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliance. Knowledge about writing processes and procedures. Basic understanding of clinical trial development and operations Daiichi Sankyo, Inc. ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and ... with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- Merck (Rahway, NJ)
- …and Trade, Distribution, Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and ... **Job Description** The Global Clinical Supply (GCS) organization is...but are not limited to:** - Participates on the Clinical Trial Team (CTT) and collaborates closely… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …+ Leads medical data review of trial data, including eligibilty criteria + Supports Global Clinical Operations in clinical trial initiation, ... people to make a difference with. **The opportunity** The Clinical Trial Physician (CTP), Director, sits within...a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster… more
- Bayer (Whippany, NJ)
- …reports, technical documents, or presentations; + Support optimization of standard methodologies in clinical trial design and operations , adopting an open ... a real difference, there's only one choice.** **Sr Director, Global Clinical Lead, Diagnostic Molecular Imaging** The...Study Report, regulatory documents, etc.); + Develop and oversee clinical trial designs (with a focus on… more
- Pfizer (New York, NY)
- …Plan and associated protocol design documents. The GDL is a key partner for other clinical and clinical operations colleagues through the lifestyle of all ... **Role Summary** The Global Development Lead (GDL) represents Clinical ...and SCS + Support appropriate interpretation and communication of clinical trial data. + Review and approve… more
- Bristol Myers Squibb (Madison, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial ... team members + May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician for provision and… more
- Pfizer (New York, NY)
- …for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations , and other functional ... trials and supports appropriate interpretation and communication of clinical trial data. + Maintains compliance with...with the approved plan and partners with key stakeholders ( clinical operations , safety risk lead, etc.) to… more
- Pfizer (New York, NY)
- …for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations , and other functional ... trials and supports appropriate interpretation and communication of clinical trial data. + Maintains compliance with...with the approved plan and partners with key stakeholders ( clinical operations , safety risk lead, etc.) to… more
- Sanofi Group (Morristown, NJ)
- … and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), ... target validation plan is essential. We are an innovative global healthcare company with one purpose: to chase the...Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial … more
- Bayer (Whippany, NJ)
- …plans, publications, and regulatory submissions; + Support optimization of standard methodologies in clinical trial operations and adopt an open learning and ... of Radiopharmaceuticals, preferably in diagnostic radiotracers; + A track record of clinical trial management/ operations of Radiopharmaceuticals and broad… more
- Bristol Myers Squibb (Madison, NJ)
- …motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key Responsibilities** + Accountable for the ... Scientists (CS) within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent;… more
