Parexel is hiring a CTIS Administrator

At Parexel, we share a common goal to improve the world's health. We take our work personally and are committed to making a difference. We are looking for a CTIS Administrator responsible for planning and delivering European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting via the Clinical Trial Information System (CTIS). You will coordinate closely with Regulatory Affairs, Clinical Trial Management, and Clinical Transparency.

What You'll Do

• Engage with Regulatory Affairs to plan the Clinical Trial Application (CTA) for upcoming EU clinical trials.
• Engage with Clinical Trial Management to determine key study milestones and country allocation.
• Coordinate with Clinical Transparency regarding redactions for CTA submission documents.
• Identify participating Member States and capture information in the CTIS database.
• Identify key study and country-level milestones and capture their dates in CTIS.
• Identify Institutions and Primary Investigators per country and capture contact details in CTIS.
• Locate applicable CTA documents and upload them into the CTIS database.
• Maintain lists of participating Member States, Institutions, and Primary Investigators throughout the study.
• Triage questions and Requests for Information (RFIs) from clinical trial application reporting.
• Engage and oversee vendors assisting with CTIS data collection and entry.
• Perform basic document management tasks including file transfer, storage, tracking, and archival.
• Develop familiarity with current global regulatory submission standards.
• Comply with required training, complete timesheets, submit expense reports, and update your CV.
• Maintain effective relationships with other platform lines, Business Units, and enabling lines.

What We're Looking For

• Bachelor’s degree.
• Minimum 1-3 years of relevant clinical essential document review experience.
• Working knowledge of the clinical drug development process, ICH/GCP, and regulatory guidelines.
• Strong familiarity with EUCTD/R and the Federal Code of Regulations.
• Ability to prioritize and manage multiple projects simultaneously.
• Effective problem-solving and decision-making skills.
• Strong interpersonal, collaboration, and stakeholder management skills.
• Good written and verbal communication.
• Highly organized and detail-oriented.
• Ability to synthesize information and demonstrate strategic thinking.
• Self-motivated, flexible, able to follow through in a fast-paced environment and meet deadlines under pressure.
• Ability to travel up to 25%.

Nice to Have

• Familiarity with Veeva Vault Clinical for CTMS and eTMF use.
• Computer skills with competency in the Microsoft Office suite.

Team & Environment

Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.

Parexel is an equal opportunity employer.