- Merck & Co. (Rahway, NJ)
- …in preparation for movement into next roles.This role will collaborate throughout Global Clinical Trial Operations local, country , and HQ levels, with ... trial management, data management, country operations and other areas. This role...required.Bachelor's Degree preferred.#MSJRRequired Skills:Adaptability, Adaptability, Clinical IT, Clinical Research Management, Clinical Study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial ... insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in...escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team,… more
- Aequor (Basking Ridge, NJ)
- …drug supply forecast for packaging and labeling operations . Support patient study needs that consider enrollment rates, country logistics for shipping and ... Duties: Participate in study team meeting, align with study ...drug supply as well as experience managing third-party contract clinical supply operations required Global experience required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides ... indications.- Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- BeOne Medicines (San Mateo, CA)
- … study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional ... within agreed timelines and budget + Leads the regional clinical operations team (including oversight of external...regional study budgets + Works closely with Clinical Business Operation on investigator fees, site… more
- BeOne Medicines (Emeryville, CA)
- …timely, quality, and efficient study planning and execution of associated clinical programs/ studies + Conduct regular program review meetings to mentor, ... will lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated Franchise(s)- therapeutic area (s) or… more
- Organon & Co. (Jersey City, NJ)
- …test articles, study records, etc.), and on-site monitoring of non- clinical studies at specific milestones. Additionally, this position will interface ... **Job Description** **The Position** The Non- Clinical Operations Lead within the Non-...Team (NCD), is responsible for operational oversight conduct outsourced non- clinical studies at contract research organizations (CROs),… more
- CSL Behring (King Of Prussia, PA)
- …Director Clinops Program Lead. **Main Responsibilities:** + Clinical Operations Strategy: Design and implement operational strategies, study management ... (more complex studies ). Continuously assess and improve clinical operations processes. Provide early input in... studies from protocol development through to Clinical Study Report (CSR) completion and Trial… more
- Organon & Co. (Jersey City, NJ)
- …TMED studies . **Responsibilities** + Manage and support the operational aspects of clinical studies from study start-up through close-out. + Manage and ... TMED Operations Lead to plan and execute studies including, but not limited to, managing study... site personnel and investigators. Competencies + Phase 1 study operations + ICH/GCP + Clinical… more
- Parexel (Charleston, WV)
- …level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies - Provide input into global ... Manage integration of project team activities - Manage strategic study operations including but not limited to...provide input into budgets, timelines, and forecasts for assigned clinical studies - Provide support for inspection… more
- Organon & Co. (Plymouth Meeting, PA)
- …to 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical ... design, execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with… more
- Organon & Co. (Plymouth Meeting, PA)
- …+ In conjunction with Non- Clinical Operations , coordinate non- clinical pharmacology and toxicology studies at Contract Research Organizations (CROs). ... study protocols and research reports. + Authorship of non- clinical sections of IND, CTA, NDA, MAA, and relevant...documents of assets in Organon portfolio. + Ensure that non- clinical studies are conducted in compliance with… more
- BeOne Medicines (Emeryville, CA)
- …and enrollment challenges. + Participate in regional and global projects, representing Clinical Operations and Study Optimization to support BeiGene ... **General Description:** As the Regional Strategic Feasibility Lead within Global Clinical Operations (GCO), you will play a vital role in collaboration with the… more
- BeOne Medicines (Emeryville, CA)
- …analytics and systems, the Global Strategic Feasibility Analytics Lead collaborates with clinical development and clinical operations stakeholders to foster ... of the studies , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional, and country… more
- Genentech (South San Francisco, CA)
- …addressing diseases with the highest societal burden by 2029 **The Opportunity** The Clinical Operations Country Head (CH) provides strategic leadership and ... the conduct of clinical trials in the country , ensuring compliance and effective operations . **_4....+ Oversight of SPOT and Vendor Management Process by Country Study Teams including metrics/KPI reviews +… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Operation Study Country Lead **Location** : US/Remote **About the Job** Join the engine of Sanofi's mission - where deep ... impossible into possible for millions. We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support US clinical… more
- Merck (Salem, OR)
- …in preparation for movement into next roles. This role will collaborate throughout Global Clinical Trial Operations local, country , and HQ levels, with trial ... management, data management, country operations and other areas. This role...\#MSJR **Required Skills:** Adaptability, Adaptability, Clinical IT, Clinical Research Management, Clinical Study … more
- Terumo Neuro (Aliso Viejo, CA)
- …The Senior Manager, CDM oversees clinical data management activities across multiple studies from study start-up through study closure. This includes ... SOPs to ensure GCP/ICH compliance for data management, database operations , clinical report writing, case report forms,...data transfer agreements and data management plans. + Review study documents, eg clinical study … more
- Genentech (South San Francisco, CA)
- …attract, develop, and retain the most talented people in the industry, within PDG's Clinical Operations Country Footprint. **Position Summary:** The Global ... Position** **The Position:** At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to...study and asset level. One asset comprises multiple clinical studies . The GOAL is accountable for… more
- Lilly (Indianapolis, IN)
- …Planning_ + Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and ... with clinical teams. + Ensure that the clinical operations team has documented the completion... studies (and Phase I and II studies where applicable) planned by country (ies)… more
