- Sun Pharmaceutical Industries, Inc. (East Millstone, NJ)
- …Prepare and implement Quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, ... lead activities. Contribute to interview process. Contribute to Clinical Development Strategy. Contribute to departmental activities including training,… more
- Sun Pharmaceutical Industries, Inc. (Pennington, NJ)
- …Prepare and implement Quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, ... Associate Director, Clinical Operations Sun Pharma Advanced Research Company Limited...planning, conduct, and reporting of assigned trials. Participate in vendor selection process with assigned PMO representative. This includes… more
- Sun Pharmaceutical Industries, Inc. (Robbinsville, NJ)
- …Prepare and implement Quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, ... Responsibilities Assigned: Lead pivotal development program(s). Team Mentoring, Motivating, Training...Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates… more
- Astellas Pharma (Northbrook, IL)
- …commitment trials (interventional and non-interventional). + This position is accountable to the Clinical Operations Lead and will lead the cross-functional ... GCP/ICH guidelines and other regulatory requirements + Manage and lead cross-functional trial teams, including vendor set-up,...and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager, Outsourcing & Vendor Management Princeton, NJ, USA Req #339 Friday, June 28, 2024 Looking for a chance to make a meaningful difference in the oncology ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and automation. + Demonstrates ability to make critical decisions related to clinical vendor agreement negotiations and escalations + Pulls data across ... **Job Description** **Sr. Manager, Development Sourcing - Development Operations, Vendor Outsourcing:** Gilead Sciences is currently seeking an industry leader… more
- Cardinal Health (Columbus, OH)
- …solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. The company provides ... We currently have a full-time job opening for a Senior Engineer of Vendor Third Party Risk Management. **_Department overview:_** The Information Security team at… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements...including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Global Head of Clinical Research and collaborates closely with the leadership of Clinical Affairs to lead clinical strategy activities and oversee all ... it is likely not legitimate. **Job Description** The Global Lead of Respiratory Clinical Affairs reports directly...(s). + Establishes and oversees activities to ensure regulatory compliance across all project teams by establishing clinical… more
- Astellas Pharma (Northbrook, IL)
- ** Clinical Operations Lead ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... arise during program and trial conduct, including escalation to Primary Operations Lead , functional management, and external vendor management to accelerate… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to inspire you and empower you to shine? Join us as a Manager, Global Clinical Supply Chain Operations Lead in Lexington, MA reporting to the Director, Global ... to our inspiring, bold mission. **_GOALS:_** + Under the direction of the Global Clinical Supply Chain (GCSC) Team Lead , the Clinical Supplies Operations… more
- Gilead Sciences, Inc. (Foster City, CA)
- …approach to proactive compliance activities. + Key stakeholders include clinical systems, TMF, RBQM, Vendor quality/oversight, thus direct experience with ... Determine, develop, execute Effectiveness Checks for applicable CAPAs + Coordination of Clinical Operations internal process audit activities + Lead activities… more
- Bristol Myers Squibb (Princeton, NJ)
- …with project/products, to Health Authorities, business partners and senior management + Lead vendor quality oversight activities and manage external quality (eg ... Quality Assurance function and ensuring the highest standards of quality and compliance in clinical research and related activities. The role is responsible… more
- Teva Pharmaceuticals (West Chester, PA)
- …and maintenance of depots, logistics and distribution, alignment on regions where clinical trials are located for optimization, ensuring compliance with local, ... + Support trend analysis for risks, gaps & issues including CAPAs and vendor initiatives for Clinical Supply Chain. Support preparation of justifications for… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... Planning, CMO operation and Distribution management. Ensures organization effectively manages vendor relationships and activities and acts as point of escalation for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + Ensure compliance with own Learning Curricula, corporate ... Data Management, and EDC extraction configuration + Knowledge of data flow between clinical data management systems, vendor devices and CDR. + Knowledge of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + Ensure compliance with own Learning Curricula, corporate ... Data Management, and EDC extraction configuration + Knowledge of data flow between clinical data management systems, vendor devices and CDR. + Knowledge of… more
- Stanford Health Care (Palo Alto, CA)
- …oversight of the clinical engineering technology domains + Participate in vendor selections + Assures architectural compliance as clinical technologies ... intellectually curious, driven, enthusiastic, meticulous and a continual learner. You will lead and be responsible for creating and owning blueprints from ideation… more
- BeiGene (Emeryville, CA)
- …of escalation for resolution of issues of the associated program(s) in the Franchise(s) + Lead and manage the Global Clinical Program Lead (GCPL)/ Global ... KPIs, and enforce quality KPIs with support from the Compliance team + Collaborate with other GCPLs to evaluate...lead efforts to deepen scientific knowledge within the Clinical Operations' function + Champions a global mindset and… more
