CTIS Administrator at Parexel | Clinical Trial & Regulatory Affairs Jobs India
Join Parexel, a global leader in clinical research, as a CTIS Administrator in India (remote). This role offers an exciting opportunity to contribute to the planning and delivery of clinical trial submissions and regulatory compliance activities under the European Medicines Agency (EMA) framework. Ideal for professionals seeking growth in regulatory affairs jobs and international clinical trial management, this position empowers you to make a meaningful impact on global healthcare through data integrity and operational excellence.
About the Company:
Parexel is one of the world’s leading global clinical research organizations, committed to advancing scientific innovation and patient safety. With decades of expertise in clinical trials, data management, and regulatory affairs, Parexel partners with top pharmaceutical and biotechnology companies to bring life-saving therapies to market. A career at Parexel means joining a collaborative, mission-driven team where your expertise contributes to transforming global healthcare outcomes.
Job Overview:
As a CTIS Administrator, you’ll be responsible for ensuring regulatory compliance and data accuracy for European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting through the Clinical Trial Information System (CTIS). This includes coordinating with Regulatory Affairs, Clinical Trial Management, and Clinical Transparency teams to manage
trial submissions, maintain documentation, and ensure accurate reporting across global study operations.- Location: Remote – India
- Category: Clinical Trials
- Job ID: R0000036088
- Job Type: Full-Time
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- 1–3 years of experience in clinical trials, documentation review, or regulatory submissions.
- Strong knowledge of the clinical drug development process and ICH/GCP guidelines.
- Familiarity with EUCTD/R and EMA regulations preferred.
- Experience with Veeva Vault Clinical (CTMS/eTMF) is advantageous.
Key Responsibilities:
- Coordinate Clinical Trial Application (CTA) activities for EU-based studies.
- Collaborate with Regulatory Affairs and Clinical Trial Management to plan study submissions.
- Capture, maintain, and update trial and country-level data within the CTIS database.
- Upload essential regulatory documents for CTA submissions.
- Track study milestones such as enrollment, completion, and cancellations.
- Manage vendor communications and Requests for Information (RFIs).
- Support document management, archival, and compliance with Parexel standards.
Skills Required:
- Strong understanding of clinical trial processes and EU regulatory systems.
- Proficiency in data management tools and regulatory documentation systems.
- Excellent communication, collaboration, and stakeholder management skills.
- Attention to detail and the ability to manage multiple tasks efficiently.
- Competency in Microsoft Office Suite; experience with clinical software is a plus.
If you’re passionate about advancing global health, Parexel offers the ideal environment for professional growth. This remote position provides flexibility, international exposure, and the opportunity to build a rewarding career in regulatory affairs while contributing to groundbreaking research worldwide.
How to Apply:
Interested applicants can apply directly through the Parexel Careers Portal to join a team dedicated to improving patient outcomes through innovation and collaboration.
