- Novo Nordisk Inc. (Atlanta, GA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data ... inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo...or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… more
- Integrated Resources, Inc (La Verne, CA)
- …. . Works on manufacturing and packaging of Client products; Assists in the inspection of Client products, Clinical Trial Material, and components. . ... in Packaging with one that will be identified for Inspection in that group. . Works on assignments that...guidance, works on the packaging of Client products and Clinical Trial Material. . Sets up and… more
- J&J Family of Companies (Columbus, OH)
- …The Senior Local Trial Manager (Sr. LTM) may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as ... Senior Local Trial Manager - Immunology - 2406178158W...(Sr. LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation… more
- Amgen (Washington, DC)
- …best work alongside other innovative, driven professionals in this meaningful role. **Local Trial Manager (LTM)** **Live** **What you will do** Let's do this. ... internal and external partners to ensure timely delivery, budget implementation of clinical trial results within the local country. **Key Activities:** +… more
- ICON Clinical Research (Lexington, KY)
- …assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as ... Files, Monitoring Files, etc.) to ensure study files are inspection ready at all timesTo facilitate and coordinate ordering/dispatch...project objectives and timelines + To Keep the Project Manager / Project Director / Clinical Operations… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...are delivering per the scope of work + Ensure clinical project audit and inspection readiness through… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies ... maintenance of study systems including but not limited to Clinical Trial + Management System (CTMS) and...accurate budget management and scope changes + Contributes to clinical project audit and inspection readiness throughout… more
- BeiGene (Emeryville, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at ... and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or… more
- BeiGene (Emeryville, CA)
- …quality study timelines and tracks progress towards these + Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial ... **General Description:** + Accountable for global study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Leads all… more
- Fresenius Medical Center (Waltham, MA)
- …Boards(IRBs) and submits to the board on behalf of the site, negotiates Clinical Trial Agreement, monitors patient recruitment. + Oversees preparation, routing ... PURPOSE AND SCOPE: The Clinical Project Manager is a high...tracking of Confidentiality Disclosure Agreements (CDA), and Clinical Trial Agreements (CTA) with input from… more
- IQVIA (Wayne, PA)
- … team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set[1]up and coordination of ... Is primary point of contact for the assigned Project Director/ Manager from the CRO responsible for the trial...in Life Sciences. * Minimum of 8 years of clinical trial experience in the pharmaceutical industry… more
- Merck (Columbus, OH)
- …updates, and maintains GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contributes to the development and/ or ... Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible...oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic… more
- University of Pennsylvania (Philadelphia, PA)
- …adverse event management. The coordinator will take an active role in preparation of trial audits and inspection . The coordinator will take a lead role ... diagnostic testing. The position reports to the Project Manager of Ophthalmology Clinical Research. Job Description...coordinator will take an active role in preparation of trial audits and inspection . The coordinator will… more
- Novo Nordisk (Lexington, MA)
- …leading roles such as inspection host & back-room lead + Experience with clinical quality assurance, clinical trial management/monitoring or GCP Audits + ... you bring a positive attitude to successfully lead the clinical inspection process while remaining calm under...process improvement themes. Relationships This position reports to a Manager in CQC, R&D Quality in the Novo Nordisk… more
- Abbott (Alameda, CA)
- …study investigators. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review of clinical data listings for completeness and ... accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively...have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. **Preferred Qualifications**… more
- Abbott (Alameda, CA)
- …study investigators. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review of clinical data listings for completeness and ... accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively...have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. + Experience… more
- ThermoFisher Scientific (Highland Heights, KY)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
