[Remote] Clinical Trial Submissions Operations - U.S

Note: The job is a remote job and is open to candidates in USA. Confidential Jobs is seeking a Clinical Trial Submissions Operations professional to support Clinical Trial Application activities across EU and UK regions. The role involves preparation, submission, quality control, and lifecycle management of CTA submissions, ensuring compliance with regulatory requirements and timelines.

Responsibilities
• Prepare and submit Clinical Trial Applications (CTAs) via the EU Clinical Trial Information System (CTIS) and the UK MHRA Integrated Research Application System (IRAS) in compliance with regulatory requirements
• Perform independent quality control (QC) of CTA submissions, including submission documents and structured data entered into Health Authority portals
• Monitor CTIS and IRAS portals during designated working hours for Health Authority notices, alerts, and correspondence, and communicate updates to relevant functional teams within required timelines
• Support CTA lifecycle activities, including preparation, submission, maintenance, responses, and archival of CTA-related documents and correspondence
• Coordinate CTA activities with cross-functional and multidisciplinary teams, acting as a central point of contact
• Maintain oversight of user access and role management for CTA-related systems and tools
• Provide subject matter expertise on CTIS and IRAS portals to functional teams during CTA preparation and submission activities
• Assist in the development and maintenance of regulatory operations work instructions and procedural documentation
• Perform User Acceptance Testing (UAT) for submission management tools, as required
• Participate in evaluations of new technologies supporting Regulatory Operations needs
• Stay current with evolving regulatory requirements and industry standards

Skills
• Bachelor's degree in Life Sciences or a related discipline, or equivalent experience
• Working knowledge of EU Clinical Trial Regulation (CTR) and UK Clinical Trials regulations, including The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
• Hands-on experience preparing and submitting regulatory applications via Health Authority portals (CTIS and/or IRAS)
• Experience supporting regulatory applications such as Clinical Trial Applications (CTAs)
• Familiarity with Electronic Document Management Systems (Documentum-based systems preferred)
• Proficiency in Microsoft Office Suite (Word, Excel, Access, PowerPoint) and SharePoint
• Strong attention to detail and accuracy in data entry and procedural execution
• Ability to manage time-sensitive, detail-intensive deliverables
• Strong communication and coordination skills in cross-functional environments
• Ability to adapt to changing regulatory and operational requirements

Benefits
• Opportunity to work on complex, global clinical trial submission activities.
• Exposure to EU and UK regulatory submission frameworks.
• Collaborative, remote working environment.
• Work on high-impact clinical trial submissions.
• Gain hands-on experience with evolving regulatory systems and submission technologies.
• Contribute to regulatory operations supporting global clinical development programs.

Company Overview
• Confidential Jobs is operated by ExecThread, Inc. (https://execthread.com). It was founded in 2015, and is headquartered in New York, NY, US, with a workforce of 201-500 employees. Its website is https://execthread.com.

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