Job Description
Manage clinical trials in the EU, ensuring compliance with regulations and company policies, while coordinating with regulatory affairs and clinical trial management teams.
The Clinical Submission Manager will be responsible for planning and delivering EU 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). This role requires a subject matter authority in Clinical Trial Application (CTA) in EU countries, partnering with EU countries on their local site strategy allocation.
Key responsibilities 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 prioritize 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.
This role requires:
- A deep understanding of the clinical drug development process, ICH/GCP, and regulatory guidelines/directives.
- Proficiency in EUCTD/R and the Federal Code of Regulations.
- Familiarity with using Veeva Vault Clinical for CTMS and eTMF.
- Effective problem-solving and decision-making skills.
- Strong interpersonal, collaboration, and stakeholder management skills, along with good written and verbal communication abilities.
Requirements include a Bachelor's degree in a related field with at least five years of functional experience in Pharma/Biotech/CRO industry, and a minimum of 1-3 years of clinical submission experience.