Parexel is inviting applications for the position of Site Start Up EUCTR I (Remote – India, Bengaluru base). This opportunity is ideal for professionals with 1–2 years of experience in clinical trial start-up, EU CTR submissions, CTIS database management, and IVDR regulatory processes.
As a global CRO (Contract Research Organization), Parexel plays a key role in clinical development, regulatory affairs, and market access, supporting sponsors worldwide. This Site Start Up EUCTR I role focuses on EUCTR submissions, CTA documentation, CTIS coordination, and Part-II regulatory compliance across EU Member States.
If you are aiming to build a career in clinical trial start-up, EU Clinical Trial Regulation (CTR), and regulatory submissions, this is a high-growth opportunity.
Job Overview
- Job Title: Site Start Up EUCTR I
- Location: India – Bengaluru (Remote)
- Experience: 1–2 Years
- Qualification: Bachelor’s Degree
- Travel Requirement: Up to 25%
- Employment Type: Full-Time
Key Responsibilities – Site Start Up EUCTR I
The selected candidate will manage EU CTR (European Clinical Trial Regulation) submission activities and CTIS coordination tasks.
1️⃣ EUCTR & CTA Submissions
- Plan and submit Phase I initial submissions
- Manage Mono-national CTA submissions
- Handle substantial & non-substantial modifications
- Ensure compliance with national regulatory requirements
2️⃣ CTIS Database Management
- Identify participating EU Member States
- Capture trial data within the CTIS database
- Upload site-level and country-level CTA documents
- Maintain milestone tracking (Study Start, Enrollment, Completion, Holds)
3️⃣ Regulatory & Stakeholder Coordination
- Collaborate with:
- Clinical Trial Management teams
- Regulatory Affairs representatives
- Clinical Transparency teams (redactions)
- Triage and respond to Requests for Information (RFI)
4️⃣ IVDR Ethics Submission Support
- Collect IVDR-required documents
- Ensure country-specific compliance
- Support ethics submission workflows
5️⃣ Lifecycle Management
- Maintain investigator and institution records
- Archive regulatory documents per compliance standards
- Monitor Part-II CTA progress aligned with trial timelines
Required Qualifications
- Bachelor’s Degree
- 1–2 years experience in:
- Clinical trial start-up
- EUCTR submissions
- CTIS platform
- Regulatory documentation
- Knowledge of:
- ICH-GCP guidelines
- EU Clinical Trial Regulation (CTR)
- IVDR regulatory framework
- Familiarity with:
- CTMS
- TMF
- MS Excel, Word, PowerPoint
- Basic project management skills
- Strong interpersonal and stakeholder management abilities
Why This Role is Important
With the implementation of the EU Clinical Trial Regulation (CTR) and mandatory use of the CTIS portal, demand for professionals skilled in:
- EUCTR submissions
- CTA lifecycle management
- IVDR documentation
- Cross-country regulatory coordination
is rapidly increasing across global CROs like Parexel.
This role provides exposure to global regulatory compliance, EU Member State submissions, and cross-functional study start-up strategy, making it highly valuable for professionals seeking long-term careers in regulatory affairs and clinical operations.
Estimated Salary (India)
Based on market benchmarks for CRO start-up specialists:
₹6,50,000 – ₹10,00,000 per annum (INR)
(Depends on experience and location)
How to Apply
