- 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...up team and regulatory affairs + Ensures regional and country information in study systems and tools… more
- Parexel (Des Moines, IA)
- …and regional study management. + Contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure ... regulations (eg FDA, EMA, NMPA, etc.). As such, the Clinical Operations Manager (COM) is responsible for...team (eg Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations , other GCTO functional areas, Pharmacovigilance… more
- Organon & Co. (Jersey City, NJ)
- …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
- Eisai, Inc (Nutley, NJ)
- …external partnerships to equip and adapt the workforce to evolving technologies.Align clinical portfolio, business strategy, clinical studies , and related ... Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country /region in scope… more
- BeOne Medicines (San Mateo, 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
- BeOne Medicines (San Mateo, 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
- 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
- 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 Operations Study Country Lead (COSCL) **Grade:** L2 **Hiring Manage:** Nicole Ferguson **Location:** Remote/Field **About the ... impossible into possible for millions. We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support US clinical… more
- Genentech (South San Francisco, CA)
- …transformative medicines addressing diseases with the highest societal burden by 2029. As a Country Clinical Operations Excellence (CoE) Lead in PDG, you ... **The Position** At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined...stakeholders across the enterprise internally and externally such as Study Teams, PDQ, Countries, pRED, gRED etc., to ensure… 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
- Genentech (South San Francisco, CA)
- …compliance. This position is central to optimizing our country operations and achieving operational excellence, particularly in study start-up activities, ... regulatory requirements. As the leader of the PDG US Country Study Start-Up Team, the cSTL's main...Team, where applicable, and sharing collective leadership with the Country Head, Clinical Operations Excellence… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …internal and external studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation ... office locations. Fully remote is not eligible._ The **Senior Clinical Study Lead** (CSL) is expected to...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… more
- ICON Clinical Research (Lenexa, KS)
- Clinical Study Manager - Lenexa, KS...industry. **Overview** : With oversight from the manager of study management or director of operations , the ... (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive...commitments and goals. With oversight from the manager of study management or director of operations , will… more
- Amgen (Washington, DC)
- … trials at a biotech, pharmaceutical, or CRO company + Feasibility experience and/or Country clinical operations experience + Understands how data and ... activities pertaining to country and site identification, feasibility and country selection within a clinical study + Partner with study team… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Director, Medical Study Operations , will oversee several of our External Sponsored Research (ESR) programs including Investigator-Initiated Studies (IIS) ... and financial management support. **As a Director in Medical Study Operations , a typical day may include...+ Support of Early Phases molecules, post-IND filing, ensure non- clinical and non-drug studies are reviewed in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …expertise in the understanding of clinical and non- clinical study protocols and associated documentation. Manages biospecimen operations for assigned ... day may include:** + Responsible for the interpretation of clinical /non- clinical study protocols and associated...inputs. + Manages biosample operations for assigned clinical /non- clinical studies to ensure company… more
- Astellas Pharma (Northbrook, IL)
- …leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables ... Country and Site Feasibility Lead will deliver the study specific Country and Site Feasibility strategy...Build relationships and engagement with local operational teams and clinical sites to proactively prepare for future studies… more
- Regeneron Pharmaceuticals (Warren, NJ)
- … Concepts (CSC) * Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases ... in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets… more
