PSI CRO Hiring Study Startup Specialist II in Bangalore | Clinical Research Jobs for Life Sciences Professionals
PSI CRO Hiring Study Startup Specialist II in Bangalore | Clinical Research Career Opportunity
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(PSI CRO Hiring Study Startup Specialist II in Bangalore) |
Introduction
PSI CRO has announced a new opportunity for the position of Study Startup Specialist II at its Bangalore office. This role is ideal for professionals with experience in clinical trial startup activities, site activation, regulatory submissions, ethics committee coordination, and clinical operations.
Candidates from Life Sciences backgrounds who have hands-on experience supporting India-based clinical trials can explore this opportunity to work with a globally recognized Contract Research Organization (CRO). The position offers exposure to study startup management, regulatory documentation, site activation planning, contract coordination, and stakeholder management across clinical research projects.
If you are looking for Clinical Research Jobs in Bangalore, Site Activation Jobs, Study Startup Specialist Jobs, Clinical Operations Careers, or CRO Jobs in India, this opportunity may align well with your career goals.
About PSI CRO
PSI CRO is a global Contract Research Organization (CRO) founded in 1995. The company specializes in providing clinical research services to pharmaceutical, biotechnology, and healthcare organizations worldwide.
Headquartered in Zug, Switzerland, PSI CRO operates across multiple countries and supports clinical development programs from study startup through study closeout. The organization is known for its expertise in clinical trial management, regulatory affairs, site activation, project management, and clinical operations.
With thousands of employees and a strong global presence, PSI CRO continues to support innovative drug development programs across therapeutic areas while maintaining high standards of quality, compliance, and operational excellence.
Job Overview Summary
The Study Startup Specialist II position focuses on coordinating and managing startup activities required before clinical trials can begin at investigational sites.
The selected candidate will work closely with project teams, clinical research associates, investigators, ethics committees, regulatory authorities, vendors, and sponsors to ensure studies are activated efficiently and in compliance with applicable regulations.
This role requires strong organizational skills, knowledge of site activation processes, experience with regulatory submissions, and the ability to coordinate multiple startup activities simultaneously.
Vacancy Details
| Particular | Details |
|---|---|
| Company | PSI CRO |
| Position | Study Startup Specialist II |
| Department | Clinical Operations / Study Startup |
| Location | Bangalore, India |
| Employment Type | Full-Time |
| Work Mode | Office-Based |
| Experience Required | Minimum 2 Years |
| Qualification | Degree in Life Sciences |
| Industry | Clinical Research / CRO |
| Category | Study Startup & Site Activation |
Responsibility Explanation
As a Study Startup Specialist II, the selected professional will play a critical role in ensuring that clinical trial sites are ready to begin participant enrollment.
Major responsibilities may include:
Site Activation Support
Coordinate all startup activities required for site activation and ensure timelines are achieved according to project requirements.
Regulatory and Ethics Submissions
Prepare and support submissions to regulatory authorities, Institutional Review Boards (IRBs), and Independent Ethics Committees (IECs).
Site Documentation Management
Collect, review, track, and maintain essential study documents required for startup approval and activation.
Contract and Budget Coordination
Support negotiations related to site agreements, contracts, and clinical trial budgets.
Study Startup Tracking
Monitor startup timelines and proactively identify delays that may impact project milestones.
Vendor Coordination
Work with vendors, investigational sites, and project teams to ensure smooth communication and document exchange.
Clinical Supply Coordination
Support investigational product distribution and study material management activities during study initiation.
Stakeholder Management
Collaborate with sponsors, investigators, project managers, and internal teams to facilitate successful startup execution.
Eligibility Criteria
Candidates applying for this opportunity should possess:
- Bachelor's or Master's Degree in Life Sciences or related disciplines.
- Minimum 2 years of full-scope Study Startup experience in India-based clinical trials.
- Strong understanding of clinical research processes.
- Knowledge of site activation procedures.
- Experience with IRB/IEC submissions.
- Familiarity with regulatory documentation requirements.
- Excellent communication skills.
- Strong organizational and planning abilities.
- Ability to manage multiple projects simultaneously.
Suitable Qualifications
The role may be relevant for candidates with:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Biotechnology
- Microbiology
- Biochemistry
- Biomedical Sciences
- Clinical Research
Skills Required
Successful candidates are expected to possess skills such as:
- Clinical Trial Startup
- Site Activation
- Regulatory Documentation
- Ethics Committee Submissions
- IRB Management
- IEC Coordination
- Clinical Operations
- Contract Negotiation
- Budget Coordination
- Vendor Management
- Clinical Research Compliance
- Project Coordination
- Stakeholder Management
- Essential Document Collection
- Communication Skills
- Time Management
- Problem Solving
- Risk Identification
These competencies are highly valued across the clinical research and CRO industry.
Salary Estimate
PSI CRO has not officially disclosed the salary package for this position.
Based on similar Study Startup Specialist roles in India, the expected compensation may range between:
₹6 LPA – ₹10 LPA
Actual salary may vary depending on:
- Experience level
- Clinical research expertise
- Previous CRO experience
- Site activation knowledge
- Negotiation during recruitment
- Company compensation policies
Interview Details
The company has not publicly shared interview details.
Candidates may typically expect:
Screening Round
Initial HR discussion regarding experience and career background.
Technical Round
Assessment of knowledge related to:
- Clinical Trial Startup
- Site Activation
- Regulatory Submissions
- IRB/IEC Processes
- Clinical Research Regulations
Final Discussion
Interaction with hiring managers and project stakeholders.
Required Documents
Candidates should keep the following documents ready before applying:
- Updated Resume/CV
- Educational Certificates
- Experience Certificates
- Current CTC Details
- Expected Salary Information
- Identity Proof
- Address Proof
- Professional Certifications (if available)
- Clinical Research Training Certificates
- Relieving Letter from Previous Employer (if applicable)
Why Join PSI CRO?
Working with PSI CRO can provide several professional advantages:
- Exposure to global clinical trials
- International clinical research environment
- Career growth opportunities
- Strong learning culture
- Clinical operations expertise
- Site activation specialization
- Professional development programs
- Global project exposure
- Competitive compensation and benefits
- Collaborative work culture
The company is recognized for delivering high-quality clinical research solutions worldwide.
How to Apply
Interested candidates can apply through the official application portal:
Candidates are advised to review all eligibility requirements before submitting their application.
Frequently Asked Questions (FAQs)
1. Is this role suitable for freshers?
No. PSI CRO requires candidates with at least 2 years of Study Startup experience in India-based clinical trials.
2. What is the job location?
The position is based in Bangalore, India.
3. Which qualifications are eligible?
Candidates with Life Sciences backgrounds such as B.Pharm, M.Pharm, Pharm.D, Biotechnology, Microbiology, and related fields may be eligible.
4. What type of experience is required?
Experience in site activation, regulatory submissions, ethics committee coordination, and study startup activities is preferred.
5. What is the estimated salary?
The estimated market range is approximately ₹6–10 LPA, depending on experience and skills.
6. Is CRO experience mandatory?
While not explicitly stated, prior CRO or clinical research experience is highly beneficial.
7. What are the key skills required?
Clinical Trial Startup, Site Activation, Regulatory Documentation, IRB/IEC Coordination, and Clinical Operations.
8. Does PSI CRO provide career growth opportunities?
Yes. The company offers training programs, mentorship, professional development, and opportunities to work on global clinical research projects.
Final Conclusion
The PSI CRO Study Startup Specialist II opportunity offers an excellent platform for experienced clinical research professionals seeking to advance their careers in study startup and site activation. The role provides exposure to regulatory submissions, clinical trial operations, ethics committee coordination, and stakeholder management within a global CRO environment.
Professionals with strong clinical research backgrounds and experience in India-based study startup activities may find this position valuable for long-term career growth in the pharmaceutical and clinical research industry.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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