- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Novo Nordisk Inc. (San Antonio, TX)
- … 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …on risk management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality assurance for regular ... We are looking for a Director Global Procurement-R&D- Inspection Readiness to be responsible to lead, support...management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …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
- 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
- Edwards Lifesciences (Irvine, CA)
- …with training matrix(es) and company SOPs + Monitors for the overall completeness and inspection readiness of the clinical trial master files + Provide ... the evidence needed to optimize patient outcomes. As the Clinical Operations Manager in Advanced Technology (AT),...Degree in related field PLUS 8 years of relevant clinical trial operations/ clinical research/ clinical… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies ... based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and … 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
- J&J Family of Companies (Columbus, OH)
- …Janssen Research & Development, LLC (6084) **Relocation Eligible:** No **Job Function** Clinical Trial Project Management **Req ID:** 2406171914W ... Functional Manager , Global Clinical Operations - Oncology...+ Ensure studies are in a constant state of inspection readiness. + Communicate with staff on program changes,… more
- Taiho Oncology (Princeton, NJ)
- …sciences is preferred. Knowledge, Skills, and Abilities: + 2 years of relevant clinical trial support or site management experience in the pharmaceutical, ... Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals. + Recognize potential obstacles and work to resolve… more
- Abbott (Alameda, CA)
- …assembling submissions. + 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. + Participate...have 3+ years of relevant experience in site monitoring, clinical project management, clinical trial … 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
- 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
