16 to 30 of 44
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 12 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 14 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 14 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 14 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 14 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 14 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 14 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 15 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 15 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 18 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 19 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 19 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 19 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 21 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 21 days ago
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