Associate

• Coordinate and perform local site start-up activities for clinical studies.
• Track start-up information, data, progress, milestones, and planned dates in CTMS and/or other tracking tools.
• File and assist with filing documents in the (e)TMF.
• Prepare, compile, submit, and maintain regulatory documentation for local clinical-trial authorities.
• Provide compliant documents and support review of technical, pre-clinical, and clinical reports.
• Interact with regulatory authorities and prepare responses to agency questions.
• Monitor regulatory updates and communicate changes to relevant stakeholders.
• Prepare, submit, and maintain ethical documentation for IEC/IRB requirements.
• Interact with IEC/IRB and prepare responses to questions.
• Adapt country SIS/ISF to site-specific requirements.
• Provide country-specific requirements affecting site-contract processes.
• Prepare, review, negotiate, and finalize CTAs, LOIs, termination letters, budgets, and other site-level agreements.
• Communicate contract status with sites and internal personnel.
• Arrange translations and obtain required site and Sponsor/Allucent signatures.
• Prepare site-specific Essential Document Packages and send them to sites.
• Collect and initially review Essential Documents and resolve discrepancies.
• Obtain authorization for shipment of Investigational Product to sites.
• Track relevant information and data in CTMS or other tracking tools.

Start-Up Associate Contractor

• Provide technical support for customers using MiniMed™ diabetes devices
• Troubleshoot device issues
• Guide users on product functionality
• Coordinate repair or replacement processes when needed
• Deliver customer support and accurate documentation
• Follow compliance and support procedures

Experience Care Associate, Polish

• Provide support to other activities undertaken by the project team on behalf of the client and the company
• Perform ICSR management activities within agreed scope and timelines
• Process Individual Case Safety Reports from all sources in compliance with applicable regulations, company procedures and client-specific requirements
• Perform ICSR follow-up, SAE/SUSAR management, including unblinding, clinical trial reconciliation and protocol review
• Review Safety Management Plans
• Perform clinical and partner reconciliation
• Manage personal data protection activities
• Handle Product Quality Complaints and interact with Quality Assurance
• Interact with Medical Information teams
• Perform MedDRA and WHO coding
• Produce database outputs and reports, including monthly client reporting data
• Support workflow and resource management
• Support pharmacovigilance processes related to ICSR management for PrimeVigilance and clients
• Perform tasks assigned under SOPs to more junior positions when applicable
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

Associate jobs in Bulgaria

Start-Up Associate Contractor

Experience Care Associate, Polish

Senior PV Associate