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Parexel, a global leader in clinical research and regulatory services, is hiring a CTIS Administrator to manage European Union Clinical Trials Directive/Regulation (EUCTD/R) submissions through the Clinical Trial Information System (CTIS).
This full-time remote position is perfect for life science graduates with experience in clinical document management, regulatory operations, or clinical trial coordination. Join Parexel to make a meaningful impact on global health while growing your career in clinical research compliance and regulatory data management.
Key Responsibilities
As a CTIS Administrator at Parexel, your responsibilities include:
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- Planning and coordinating Clinical Trial Applications (CTA) under EUCTD/R regulations.
- Engaging with Regulatory Affairs and Clinical Trial Management teams to track study milestones.
- Managing Member State/country-level data within the CTIS database.
- Coordinating with Clinical Transparency teams for document redactions and regulatory uploads.
- Maintaining study and investigator information in the EMA CTIS system throughout the trial lifecycle.
- Handling Requests for Information (RFIs) and supporting regulatory submissions.
- Performing document management activities including archival, tracking, and file transfer.
- Ensuring compliance with ICH-GCP, EMA, and Parexel standards.
Qualifications & Requirements
Education:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
Experience:
- 1–3 years of experience in clinical essential document review or regulatory operations.
Skills Required:
- Strong knowledge of clinical trial processes, EUCTD/R, and ICH-GCP guidelines.
- Familiarity with Veeva Vault Clinical (CTMS/eTMF).
- Excellent organizational, communication, and stakeholder management skills.
- Proficiency in MS Office Suite.
- Ability to handle multiple projects and meet tight deadlines.
Additional Information:
- Remote work flexibility (India-based).
- May require up to 25% travel for coordination or audits.
Why Join Parexel?
- Contribute to life-changing therapies improving global health.
- Collaborate with leading experts in clinical research and regulatory operations.
- Remote work options across major Indian cities.
- Competitive compensation and professional growth opportunities.
How to Apply
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