Position: Clinical Operations Assistant
Location: Bengaluru, India
Employment Type: Full-time
Experience Required: 1–2 years
Job Description
About Parexel
Parexel International is a leading global Clinical Research Organization (CRO) that supports pharmaceutical, biotechnology, and medical device innovations. With a strong presence in over 100 countries, Parexel is known for its cutting-edge clinical trials, regulatory consulting, and patient-centric research solutions.
Joining Parexel means being part of a dynamic team that accelerates drug development and improves patient outcomes worldwide.
Key Responsibilities
1. Central File & Documentation Management
- Track, scan, label, and upload clinical documents to Central File (CF) and Work In Progress (WIP) systems.
- Archive wet-ink documents following the Central File Maintenance Plan (CFMP).
- Conduct quality checks to ensure compliance with SOPs and regulatory standards.
- Handle photocopying, printing, and document retrieval as needed.
2. Clinical Trial Support & Tracking
- Maintain study-specific trackers and Clinical Trial Management Systems (CTMS).
- Monitor reporting timelines for regulatory submissions and site safety updates.
- Assist with translation workflows and approvals via platforms like Oracle.
3. Administrative & Site Coordination
- Manage courier shipments, signature collections, and invoice processing.
- Support Japanese clinical sites with document coordination.
Eligibility Criteria
Educational Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related healthcare fields.
- Equivalent nursing or clinical research certifications are also acceptable.
Skills & Experience
- 1–2 years of experience in clinical research, CROs, or pharma/biotech.
- Familiarity with CTMS, Impact Harmony, and eTMF systems.
- Strong organizational, communication, and time-management skills.
- Knowledge of ICH-GCP, regulatory documentation, and clinical trial protocols.
Why Join Parexel?
✅ Global Exposure – Work on international clinical trials with top pharmaceutical companies.
✅ Career Growth – Access to APEX program for fast-tracked promotions into clinical roles.
✅ Learning & Development – Structured training in clinical operations and regulatory compliance.
✅ Work-Life Balance – Supportive work culture with flexible policies.