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Develop and characterize for the siRNA pipeline products Analyze and interpret results Plan future experiments based on findings to advance understanding of the product candidates and method development Generate and review SOPs, test records, and protocols for testing of RNA therapeutic products (internally and externally) Write/review analytical method protocols/stabilit
Posted 3 days ago
Design, create, update, and test clinical databases including eCRF's, folders, matrices, data dictionaries/code lists, unit dictionaries, edit checks/rules, derivations, custom functions, standard, and custom reports Comply with data standards aligned with industry standards (e.g., CDISC) and regulatory guidance Create metric reports and data listings Ensure appropriate m
Posted 3 days ago
Create and drive study level timeline Develop overall feasibility concept, enrollment plan, study budget, Study Management plan, and all associated documents Provide input on operational aspects of the protocol Ensure regulatory and GCP compliance Oversee the TMF with periodic audits Assist in vendor selection and management including issue escalation Collaborate with tea
Posted 3 days ago
Establish and maintain technology standards Evaluate and direct new technology designs Provide technical architectural expertise, play a vital role in designing, enhancing, implementing, and scaling application platforms Solve technology challenges in internal enterprise applications and create solutions that will solve problems that have not yet been fully formulated Ser
Posted 3 days ago
Support Central Services staff in an administrative capacity Oversee Study Site Management and Central Services shared mailboxes Participate and facilitate the onboarding and prerequisite process for applicable external vendors new to Sponsor Create and maintain all related purchase orders Initiate and administer electronic purchase requisitions Manage issues related to i
Posted 7 days ago
Serve as technical lead in multi disciplined project teams Identify opportunities for cost reduction or process efficiency improvements through standardization and automation Collaborate with suppliers to evaluate, select, and validate cost effective raw materials that meet industry standards Develop and manage projects consistent with department/corporate goals Test equi
Posted 7 days ago
Perform Investigator feasibility and capability assessments to support site evaluation Collect/review site documents and ensure quality/accuracy of documents in accordance to ICH/GCP and local regulations, requirements, and guidelines Establish initial and ongoing CA/EC submissions Support contract/budget negotiations and payment processes Review and/or input to study pro
Posted 7 days ago
Collaborate with product management to understand and discover requirements Participate as an active member of a scrum team Provide regular status updates on assigned tasks Work with QA to ensure a high quality product Trouble shoot issues found in production Foster a strong software engineer environment through code reviews and unit tests EXPERIENCE Minimum of 3 years of
Posted 9 days ago
Perform Investigator feasibility and capability assessments to support site evaluation Collect/review site documents and ensure quality/accuracy of documents in accordance to ICH/GCP and local regulations, requirements, and guidelines Establish initial and ongoing CA/EC submissions Support contract/budget negotiations and payment processes Review and/or input to study pro
Posted 9 days ago
Perform Investigator feasibility and capability assessments to support site evaluation Collect/review site documents and ensure quality/accuracy of documents in accordance to ICH/GCP and local regulations, requirements, and guidelines Establish initial and ongoing CA/EC submissions Support contract/budget negotiations and payment processes Review and/or input to study pro
Posted 9 days ago
Grow and lead the internal technology organization Establish and drive the organization's quality focused culture Find, enable, and empower director level leadership Collaborate with senior executives on matters of strategic/operational planning, international operations, organizational change, business/performance management, and overall leadership of the company Provide
Posted 10 days ago
Program SAS Non System Edit Checks, Protocol Deviations, and SAS Data Listings Support the maintenance of the Non System Edit Check Global Library to ensure consistency across programs, studies, and concordance with the EDC Global Library Create SAS program Specifications for Non System Edit Checks based on CRF and non CRF data Participate in the development/review of dat
Posted 11 days ago
Participate in project initiatives for new and existing systems (enhancements or upgrades to existing systems, install new software applications, document user requirements, perform development/configuration of software, execute system and validation testing, create/revise SOP's, and conduct training) Collaborate with software vendors and other UT departments Provide brea
Posted 11 days ago
The QA Specialist Product Complaints is responsible for ensuring compliance of the Product Quality Complaint (PQC) process as well as participating in additional aspects of the post market surveillance program. This role will initiate incoming Product Complaints, lead and/or facilitate investigations both at client and at Contract Manufacturing Organizations (CMOs), and w
Posted 14 days ago
Author and maintain study related documents (protocol synopsis, protocol, CSR, IB, etc.) Evaluate and provide medical/scientific input to safety sections of study related documents generated by other departments Develop and maintain standardized clinical study documents related to the Clinical Research department (protocol template, safety reporting standard, SOP, etc.) R
Posted 15 days ago
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