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Collaborate internally and with vendors to evaluate, select, and validate cost effective primary, secondary, and tertiary packaging materials, equipment, and machines that meet industry standards for sterile barrier packaging systems and other packaging systems Support cost reduction, process efficiency, and/or quality improvements through standardization, automation, and
Posted 1 day ago
Support the development, proofing, and distribution of clinical study and project tracking reports Create the Clinical Trial Master File (TMF) in accordance with agreed file structure Ensure ongoing routine maintenance of the TMF so that files are complete and audit ready Assist with the generation and distribution of initial/ongoing study supplies, including study manual
Posted 2 days ago
Ensure that Quality Systems are designed/operating in a way that provides appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU Develop/Lead Quality Engineers as they continuously improve the manufacturing plant processes and procedures to meet quality, compliance, and business objectives Tre
Posted 4 days ago
Provide focused quality engineering support and assume responsibility for timely/effective coordination and/or execution of assigned development project activities Establish effective corrective action plans Lead implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal/external requirements Serve as an effective lea
Posted 4 days ago
Follow and ensure assigned studies are conducting in compliance with the currently approved protocol(s), amendment(s), Standard Operating Procedures, Code of Federal Regulations (CFR), Good Clinical Practice (ICG GCP), and local or country regulations Participate in Investigator feasibility and selection process Perform site qualification (pre study), site initiation, rou
Posted 4 days ago
Manage, from project start up to database lock, the monitoring of clinical trials data for completeness, accuracy, consistency, and that data meets quality standards expected for reporting to regulatory bodies Ensure data integrity and compliance and manage data capture, editing, and transfer activities Contribute to the design of protocols/database design, review of elec
Posted 4 days ago
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 4 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 4 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 4 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 4 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 5 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 5 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 8 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 9 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 9 days ago
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