- 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …roadmap for Global Development data products, spanning protocol development through clinical trial disclosure. + Develop data products through agile delivery ... closely with Global Development Data Science teams, Clinical Development, Operations , and Regulatory stakeholders, as...disclosure datasets. **Skills & Expertise** + Deep knowledge of Global Development processes, clinical trial … more
- Actalent (Somerville, NJ)
- Job Title: Clinical Trial SpecialistJob Description As a Clinical Trial Specialist, you will coordinate the initiation and activation of all new ... clinical trial protocols. This involves verifying approvals...effectively. Work Environment The position is part of a clinical operations team with 40 full-time employees,… more
- Taiho Oncology (Princeton, NJ)
- … clinical studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative, and global cross-functional environment. ... for the planning and execution of one or multiple global trials by managing all aspects of trial...mentorship, and training for others in Clinical Operations . + Support Clinical Operation … 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
- Taiho Oncology (Princeton, NJ)
- …study documentation and Trial Master File. The SA supports the Clinical Operations department with developing processes and procedures and sharing lessons ... impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of...Knowledge, Skills, and Abilities: + 2 years of relevant clinical trial support or site management experience… 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 (Princeton, 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
- Bristol Myers Squibb (Princeton, NJ)
- …15+ years of demonstrable experience in pharmaceutical industry with proven expertise in clinical trial execution, data acquisition, and analysis reporting on a ... our diverse team! As the Product Manager for the Clinical Data Ecosystem within Global Drug Development...data products, and analytic ready data solutions for GDD Clinical Intelligence ( Trial Simulation & Modeling, … more
