16 to 30 of 47
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 11 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 11 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 11 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 11 days ago
Assess complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting Perform and/or coordinate complaint investigations and gather additional information Collaborate with other departments to complete investigation reports Evaluate all information from a tec
Posted 12 days ago
Create comprehensive Monitoring Plans (MP) Plan and manage study startup, including site identification qualification selection and initiation activities Oversee Clinical Monitoring activities through site activation, maintenance, and study closure Develop study specific templates for use by the Clinical Monitoring team (CRAs) and/or sites Establish clinical monitoring st
Posted 12 days ago
Plan, conduct, and complete investigations under supervision Assist research staff with prospective and retrospective research projects Perform routine data analysis and verify/correct data entry Write and edit experimental results for publication in technical/peer reviewed journals Prepare reports, protocols, and data summaries Create and/or maintain laboratory standard
Posted 15 days ago
Implement and maintain a comprehensive risk based GCP compliance program Manage, conduct, and report assigned investigator site, vendor, and internal process/function audits on site and remotely Review and approve audit responses and evaluate adequacy of corrective and/or preventative actions Provide SME support during global regulatory agency inspections and third party
Posted 16 days ago
Oversee and certify all new work, repair work, or maintenance done on the ESS system and certify the functionality of all equipment and capabilities installed on the system Maintain and monitor the database performance to ensure the specifications of the system are met Facilitate basic application training to Security personnel using ESS Implement established policies and
Posted 16 days ago
Lead internal audits of facilities based on the FDA System Based Inspection Policy and general cGMP Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings Review and evaluate internal audit responses against current industry standards, regulations, and guidelines to assure compliance Drive closure of corrective and preventative action
Posted 16 days ago
Assist with multi site projects in industry sponsored clinical trials Produce site specific contracts from country clinical trial agreement (CTA) template Review and own site specific contracts from country template Submit proposed CTA and investigator budget for site review Negotiate budget/contract with site and track in Excel Collaborate with the contract research orga
Posted 18 days ago
Ensure clear documentation of the process that was followed in the form of specifications, trackers, and checklists Provide QC oversight of CRO deliverables Develop SAS or other programs and specifications for production of output to support study needs (publications, safety reporting, ad hoc analyses, etc.) in a timely fashion Verify other programmers' results Validate s
Posted 18 days ago
Serve as primary source of medical accountability Oversee clinical trial(s) in respective therapeutic area Act as a medical lead EXPERIENCE Minimum of 4 years of experience in clinical research, including the design and execution of clinical trials, within a pharmaceutical or biotech environment required Experience in a contract research organization or academic instituti
Posted 19 days ago
Study literature and consult with internal experts, external advisors, and advisory boards Contribute to identifying experts Identify the desired study population by delineating subject eligibility criteria for study participation and pursue the demonstration of drug activity by selecting clinical and mechanistic endpoints Act as clinical study leader Lead the Global Deve
Posted 19 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 19 days ago
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