Looking for Parexel Site Start Up Specialist Jobs in Hyderabad? Parexel is hiring experienced clinical research professionals to support global clinical trial site activation and regulatory documentation. If you have experience in Clinical Research, Site Start-Up, TMF, eTMF, Regulatory Documentation, ICH-GCP, or Clinical Operations, this opportunity offers an excellent career path with one of the world’s leading Contract Research Organizations (CROs).
The role focuses on coordinating investigator site documentation, regulatory submissions, Trial Master File (TMF) management, and ensuring inspection-ready documentation throughout the site activation process.
About Parexel
Parexel is a global clinical research organization dedicated to improving patient health by supporting pharmaceutical, biotechnology, and medical device companies throughout the clinical development lifecycle. With operations across more than 100 countries, Parexel delivers innovative solutions in clinical trials, regulatory affairs, market access, and consulting.
Job Details
| Particular | Details |
|---|---|
| Company | Parexel |
| Position | Site Start Up Specialist |
| Location | Hyderabad, India |
| Job Type | Full-Time |
| Experience | 1โ2 Years |
| Qualification | Bachelor’s Degree (Advanced Degree may substitute experience) |
| Industry | Clinical Research / CRO |
| Department | Global Site Start-Up |
Key Responsibilities
As a Site Start Up Specialist, you will:
- Support investigator site activation activities for global clinical trials.
- Coordinate collection, review, and tracking of regulatory documentation.
- Prepare and distribute complete regulatory document packages to clinical sites.
- Coordinate Institutional Review Board (IRB) and Ethics Committee documentation.
- Support Central IRB (CIRB) and Local IRB (LIRB) submission activities.
- Review investigator site essential documents for completeness and quality.
- Upload and maintain essential documents within the electronic Trial Master File (eTMF).
- Ensure Trial Master File documentation remains inspection-ready.
- Track translation requirements and coordinate with external vendors.
- Monitor document timelines and provide regular status updates to study teams.
- Work closely with CRO partners and internal stakeholders to resolve documentation issues.
- Support regulatory compliance with ICH-GCP, TMF standards, SOPs, and country-specific regulations.
- Assist study teams to ensure documentation approval before initial drug shipment.
- Maintain accurate study metrics and reporting.
Required Qualifications
Candidates should possess:
- Bachelor’s Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or related discipline.
- Minimum 1โ2 years of relevant clinical research or site start-up experience.
- Advanced degree may be considered in place of work experience.
- Working knowledge of clinical trial documentation.
- Understanding of Trial Master File (TMF) and electronic TMF systems.
- Familiarity with ICH-GCP guidelines.
- Knowledge of regulatory documentation requirements.
- Strong organizational and documentation management skills.
- Excellent communication and stakeholder management abilities.
- Proficiency in Microsoft Excel, Word, PowerPoint, and Project.
- Basic understanding of clinical drug development and medical terminology.
Preferred Skills
- Clinical Trial Site Start-Up
- Trial Master File (TMF)
- eTMF Systems
- Regulatory Documentation
- Clinical Operations
- Site Activation
- Investigator Documentation
- ICH-GCP
- CRO Operations
- Clinical Research
- Inspection Readiness
- Document Quality Review
Why Join Parexel?
Parexel offers employees the opportunity to contribute to life-changing therapies while working in a collaborative global environment.
Benefits include:
- Global clinical research exposure
- Career development opportunities
- Learning and certification programs
- Hybrid work opportunities (role dependent)
- International project experience
- Inclusive workplace culture
- Competitive compensation
- Comprehensive employee benefits
- Long-term career growth within clinical operations
Salary
Based on current industry standards for Site Start-Up Specialists in Hyderabad, the expected annual salary is approximately:
โน7,50,000 โ โน11,50,000 per annum (CTC)
Actual compensation depends on experience, skills, and interview performance.
How to Apply
