- Astellas Pharma (Northbrook, IL)
- …regulatory commitment trials (interventional and non-interventional). This position is accountable to the Clinical Trial Lead and Operations Lead for trial ... systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders + Proactively… more
- Astellas Pharma (Northbrook, IL)
- …the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes ... trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables. +… more
- US Tech Solutions (IL)
- …certification What positions/background experience do you feel are successful in this role ** Clinical trial manager , Clinical Development Manager ... The Clinical Transformation Manager is accountable for delivering clinical transformation initiatives focusing on the following areas: * Clinical … more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and alignment of end-to-end clinical supply chain management to support clinical trial execution. This position will be responsible for supporting the ... **Overview** The Manager , Clinical Supply and Logistics will be...strategic planning and execution of new clinical trial supply chains on time and within… more
- Edwards Lifesciences (Springfield, IL)
- …exam results for consistency with case report form, and determining if clinical trial /study subject documentation is within parameters of study hypothesis, ... as well as monitoring clinical trial /study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Leading in the… more
- Datavant (Springfield, IL)
- …+ Deep understanding of CRO operations, data workflows, and the intersection of clinical trial data with RWD. + Knowledge of data privacy, interoperability ... across the clinical research ecosystem by deepening our partnerships with Clinical Research Organizations (CROs). The **CRO Channel Manager ** will be… more
- Merck (Springfield, IL)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... systems and management of regulatory inspections. + Profound knowledge and comprehension of clinical development programs, clinical trial processes as well… more
- Edwards Lifesciences (Chicago, IL)
- …interventional and/or structural heart environments and current treatment options or have other clinical and/or clinical trial experience. + Experience in ... + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal...Strong knowledge of statistical analyses, study design methodologies, and clinical trial protocol development. + Advanced working… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …investigator sites. This role plays a critical part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to ... The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting...executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** across Contract Research Organizations (CROs),… more
- Parexel (Springfield, IL)
- …associated with the set-up, running and close-out of sites in a clinical trial . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study ... quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more
- ThermoFisher Scientific (Chicago, IL)
- …as required. Ensures study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC check of reports generated ... the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure… more
- ThermoFisher Scientific (Chicago, IL)
- …the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure ... status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures...study systems are updated per agreed study conventions (eg Clinical Trial Management System). Facilitates effective communication… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …client needs and internal capabilities. + Promote Thermo Fisher's broad suite of clinical trial support services, including Clinical Ancillary Management, ... years of progressive experience in account management or business development within clinical trial services, CDMO, logistics, or pharmaceutical operations. +… more
- Parexel (Springfield, IL)
- …Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody ... The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager , Study Managers, and… more
- Astellas Pharma (Northbrook, IL)
- …developing and delivering training via various methods + Must have knowledge of clinical trial conduct, including multi-center, global trials. + Must have strong ... strategy & management + Process, Training & Development + Trial Master File + Clinical Operational Standards...operations within site monitoring and management function focusing on Clinical Site Manager training and oversight to… more
- PCI Pharma Services (Rockford, IL)
- …to gather supporting information to be captured within Proposals. + Reviews clinical trial strategies presented within Request-for-Quote (RFQ) and calculates ... of PCI. Working with Business Development Executives, providing high quality clinical packaging and distribution proposals within expected timeframe. Based on quote… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …adheres to the approved core scientific narrative and lexicon, accurately reflects clinical trial data, and maintains consistency across global materials + ... The Manager , Medical Core Content is a team-level operational...and production of scientific assets, ensuring they accurately reflect clinical data, adhere to the core scientific narrative, and… more
- AbbVie (North Chicago, IL)
- …North Chicago, IL; Florham Park, NJ; San Francisco, CA or Irvine, CA. The Manager , Clinical Data and Reporting Standards (CDARS) proactively participates in the ... and reporting standards in support of AbbVie's portfolio of clinical trials, and ensuring AbbVie's conformance to CDISC standards...to CDISC + Review and provide feedback on SDTM Trial Design Domains + Oversee the creation of SDTM… more
- Edwards Lifesciences (Chicago, IL)
- …you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality ... boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and… more
- Sumitomo Pharma (Springfield, IL)
- …Serve as a subject matter expert (SME) in study protocol design, review interim clinical trial reports, clinical study reports, safety summary documents, and ... website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Senior Manager , Pharmacovigilance Scientist serves as the primary Pharmacovigilance and Risk… more