1 to 15 of 45
Sort by: Date | Relevance
Manage inbound inquires (Phone, Email, Web) across multiple company program(s) Inform callers of distribution models for internal products Provide contact information for non brand specific community resources Share affordability options for company products Triage appropriate cases to internal field teams and inbound calls to appropriate contact points Document and escal
Posted 2 days ago
Create plans/strategies and implement systems to ensure process performance Support the manufacturing processes on a daily basis Work with operations and various other departments to ensure quality performance of product and processes Lead and help develop the manufacturing processes for all products Resolve quality issues with suppliers and partner with internal customer
Posted 3 days ago
Assist in the review, development, and writing of clinical trial documents/manuals Create Master ICF template, review or approve site changes, and update template for new risks/amendments Participate in the feasibility and evaluation of investigative sites Coordinate/monitor activities at investigational sites, review monitoring trip reports, and support the US monitoring
Posted 3 days ago
Monitor the adherence to ICH/GCP Guidelines, regulatory requirements, and client policies as it relates to the completeness/accuracy of the TMF Ensure the required documents reside in the TMF as per the Study Specific Master TMF Plan and Master TMF Index and are always inspection ready Work with study team to adhere to the TMF Plan and to update the Study Master TMF Index
Posted 4 days ago
Participate in project management meetings and provide an overview of TMF status, clinical study administration, resources, quality, and workload on a regular basis Communicate effectively with clinical study administration vendors Coordinate Investigator/Vendor payments and track payments/accruals Aid in data listing review and clinical study report listing review Overse
Posted 4 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 5 days ago
Manage sourcing database for supplier relationship management, vendor interaction, and day to day activities associated to category operations Support due diligence necessary on the process to identify sources of supply or find new vendors Help develop and release RFI and RFP documents Assist users with documentation required to submit purchase requests Lend support of Ca
Posted 5 days ago
Prepare study documents/manuals (consent forms, site instructions, study specific material, etc.) Ensure tracking of essential documents are received and filed in the TMF, review site documents for accuracy, and provide clinical team support with TMF filing/management Track patient status throughout the study at investigative sites Review and approve trip reports, track d
Posted 6 days ago
Create CRA selection forms after CRA Ambassador has met with CRO CRA, route for signature to CRA Ambassador, and file in study specific TMF for staff who interview CRA candidates Oversee training, review training matrix, and complete spot checks in TMF to ensure sites/CRAs have completed training Review TMF, including filing and QC support Evaluate Trip Reports Participat
Posted 6 days ago
Oversee eCRF design, database set up, user acceptance testing (UAT), data collection, edit checks and offline listings review, external data reconciliation, medical coding, quality control of database, database locks, and archival of data management documents Represent Data Management on the Clinical Trial Working Group for assigned studies Provide mentoring and training
Posted 6 days ago
Collaborate with the cross functional team leads to prioritize and align deliverables Provide regulatory support to the assigned teams Oversee and prepare documentation to support regulatory filings to ensure accuracy, applicability, consistency, and control of regulatory documents Interact with SMEs for accuracy of content Assist with the development of technical documen
Posted 6 days ago
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 10 days 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 11 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 13 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 13 days ago
Email this Job to Yourself or a Friend
Indicates required fields