Parexel is hiring for the role of Site Start-Up EUCTR I in Hyderabad, India. This position is part of clinical trial start-up operations focused on EU Clinical Trials Regulation (EUCTR) submissions, CTIS database management, and cross-functional regulatory coordination.
This is an excellent opportunity for candidates interested in clinical research, regulatory affairs, EU CTR submissions, CTIS operations, and clinical trial start-up processes within a global clinical development organization.
About the Role
The Site Start-Up EUCTR I role supports planning and execution of EU Clinical Trial Application (CTA) activities, including Phase I initial submissions, mono-national submissions, and modifications under EU CTR guidelines.
The position requires coordination with clinical operations, regulatory affairs, and transparency teams to ensure compliant and timely trial submissions.
Key Responsibilities
- Support planning and submission of EUCTR clinical trial applications (CTA)
- Manage Phase I, mono-national, substantial, and non-substantial modifications
- Coordinate with Clinical Trial Management teams for study milestones and country allocation
- Maintain study data in CTIS (Clinical Trials Information System)
- Identify participating EU Member States, institutions, and principal investigators
- Upload and manage essential trial documentation in CTIS
- Ensure compliance with EU CTR regulatory requirements
- Support IVDR-related ethics submission documentation
- Track study milestones such as study start, enrollment start, and completion
- Manage Requests for Information (RFI) and coordinate responses
- Ensure proper archival of regulatory trial documents
- Collaborate with cross-functional clinical and regulatory stakeholders
Required Qualifications
- Bachelorโs degree in life sciences, pharmacy, biotechnology, or related field
- 1โ2 years of experience in clinical research, clinical trial start-up, or regulatory affairs
- Knowledge of ICH-GCP guidelines, EU CTR, and IVDR regulations
- Basic understanding of CTMS and TMF systems
- Proficiency in MS Office tools (Excel, Word, PowerPoint)
- Strong communication and coordination skills
- Ability to manage timelines and prioritize tasks effectively
- Analytical and detail-oriented approach to clinical trial data
- Exposure to clinical drug development lifecycle is preferred
Preferred Skills
- Experience in clinical trial start-up operations
- Familiarity with CTIS submissions and EU regulatory processes
- Cross-functional team collaboration experience
- Basic project management exposure
Benefits of Working at Parexel
- Global exposure to clinical development projects
- Opportunity to work on EU regulatory submissions
- Structured career growth in clinical research
- Collaborative and inclusive work environment
- Learning opportunities in CTIS, EU CTR, and regulatory systems
- Competitive compensation and industry-standard benefits
Salary Range (India)
Estimated salary for Site Start-Up EUCTR I in Hyderabad:
โน4.5 LPA โ โน7.5 LPA (approx., based on experience and industry benchmarks)
How to Apply
