- 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
- 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 ... implement the operational strategic direction and guidance for respective clinical studies + A data driven approach...EDC + Experience in global clinical trial operations including experience developing protocols and key study… 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 ... Relocation is provided to those who qualify._ 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
- 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
- Medtronic (Mounds View, MN)
- …methodologies, including study design, implementation, and reporting. + Experience with Clinical Operations and interfacing with CRO teams. + Experience in ... study tasks under the guidance of a Clinical Study Manager. Success in this role...sciences, or related medical/scientific field. + Experience conducting/working on clinical studies and managing clinical … more
- Lilly (Indianapolis, IN)
- …and information to investigators and site personnel. + Serve as resource to clinical operations personnel/ clinical research monitors, investigators and ... years). + Responsible for the scientific training of the clinical study team. + Acts as scientific...or have completed the comparable level of post-medical school clinical training relevant to the country of… more
- Terumo Neuro (Aliso Viejo, CA)
- …direction to clinical study teams and cross-functional partners; ensuring clinical studies are conducted to the highest ethical and safety standards. Job ... of global regulations and/or standards governing the conduct of clinical studies (eg, 21 Code of Federal...development, execution, and closure. 10. Ability to concisely interpret clinical study results, safety reporting, data integrity,… more
- Genentech (South San Francisco, CA)
- …the Country Head, Country Performance and Analytics Lead (APO Lead), Clinical Operations Excellence Lead (COE Lead), and other cTALs. + Partner with CoE ... **The Position** At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined... country TA strategy. + Accountable for the country delivery of all clinical studies… more
- Lilly (San Diego, CA)
- …hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations , and other stakeholders to optimize study design and ... design early clinical studies that efficiently test therapeutic...Translational Medicine, Clinical Pharmacology, Quantitative Systems Pharmacology, Clinical Operations , Regulatory Affairs, and Search and… more
- Lilly (Boston, MA)
- …regulatory submissions, investigator meetings, and advisory boards. + Work with the Clinical Operations team to identify and resolve trial-related issues, ... ensuring smooth execution and compliance. + Collaborate closely with the clinical operations , regulatory, and data management teams to ensure timely 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
- 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
- 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
- AdventHealth (Orlando, FL)
- …administrative processes required for the assessment, review and ultimately the initiation of clinical trials and research studies for a minimum of three ... **Program Manager - Study Intake AdventHealth Orlando** **All the benefits and...research environment OR + Three (3) years' experience in clinical trial operations from execution through completion… more