Clinical Submission Manager

The Clinical Submission Manager will have responsibility for planning and delivery of European Union Clinical Trials Regulation (EUCTR) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role. The position requires a subject matter authority in Clinical Trial Application (CTA) in EU countries, partnering with EU countries on their local site strategy allocation. In this role, a typical day might include:

• Engage with Regulatory Affairs and Clinical Trial Management to plan Clinical Trial Applications (CTA) and determine key study achievements and country allocation strategies.
• Ensure trials align with national regulatory requirements, strategize submissions for timely approvals, and archive all trial-related documents in compliance with regulations and company policies.
• Identify and capture key study achievements, participating countries, institutions, and primary investigators in the CTIS database, and manage this information throughout the study lifecycle.
• Implement risk management strategies to mitigate potential issues impacting Part II activities and prioritise any questions or requests for information related to clinical trial applications.
• Oversee vendors involved in collecting and maintaining CTA information, and coordinate with local ethics committees for approvals and addressing concerns.
• Supervise and report on the progress of Part II activities, ensuring alignment with trial timelines and objectives, and stay updated on regulatory changes and industry standard methodologies to improve processes.
  
  You have an innate understanding of the clinical drug development process, ICH/GCP, and regulatory guidelines/directives.
• You are fully proficient on EUCTD/R and the Federal Code of Regulations.
• You should be familiar with using Veeva Vault Clinical for CTMS and eTMF.
• You are at ease with effective problem-solving and decision-making skills.
• You posses strong interpersonal, collaboration, and stakeholder management skills, along with good written and verbal communication abilities.
To be considered, you must have a Bachelor's degree in a related field with at least five years of functional experience in Pharma/Biotech/CRO industry. 7+ years' of relevant experience, and a minimum of 1-3 years' experience of clinical submission experience. An innate ability to prioritize and run multiple projects simultaneously.