PSI CRO is hiring for the position of Study Startup Specialist II in Bangalore. This opportunity is suitable for life science professionals with hands-on experience in clinical trial study startup and site activation activities in India.
The PSI CRO Study Startup Specialist II job focuses on coordinating clinical study activation at the country and site level. The selected candidate will work closely with project teams, investigational sites, ethics committees, regulatory authorities, vendors, and other stakeholders to help clinical research projects start smoothly and on schedule.
PSI CRO is a global contract research organization (CRO) founded in 1995 and works across clinical research and drug development. Candidates looking for clinical research jobs in Bangalore, particularly in study startup, site activation, regulatory submissions, and clinical operations, can consider this opportunity.
Job Overview
As a Study Startup Specialist II at PSI CRO, you will support and coordinate study startup activities for India-based clinical trials. The position involves site activation, regulatory and ethics submissions, site documentation, contracts and budgets, study supplies, and startup timeline management.
This is an office-based position in PSI CRO’s Bangalore office.
Key Responsibilities
The Study Startup Specialist II will be responsible for:
- Collaborating with project teams to manage site activation activities.
- Facilitating site agreements and contract negotiations.
- Supporting site budget negotiations.
- Collecting essential site documents required for IRB/IEC submissions and IP-RED processes.
- Coordinating translation and review of study-specific documents.
- Identifying study startup issues and escalating project-specific concerns when required.
- Preparing and submitting study dossiers to investigational sites.
- Preparing submissions to competent authorities and IRBs/IECs.
- Preparing IP-RED packages.
- Supporting the initial distribution of Investigational Products (IP) and clinical study supplies.
- Coordinating information and documentation exchange with investigational sites, off-site facilities, and vendors.
- Participating in the development of site-specific study startup timelines.
- Supporting enrolment projections.
- Tracking startup activities to ensure site activation targets are achieved.
Qualifications and Eligibility
Candidates applying for the PSI CRO Study Startup Specialist II vacancy should meet the following requirements:
- College or university degree in Life Sciences, or an equivalent combination of education, training, and relevant experience.
- At least 2 years of full-scope Study Startup experience in India-based clinical trials.
- Full professional working proficiency in English.
- Strong communication and organizational skills.
- Ability to negotiate effectively with different stakeholders.
- Ability to establish and maintain professional relationships across different organizational levels.
Which Degrees Can Apply?
The official requirement is a College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
Relevant educational backgrounds may include degrees such as B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Biomedical Sciences, Clinical Research, and other related life science disciplines, subject to the employer’s assessment of equivalency.
Important: PSI CRO specifically requires at least two years of full-scope study startup experience in India-based trials, so this role is not primarily a fresher-level position.
Skills Relevant to the Role
Candidates with knowledge or experience in the following areas may be particularly aligned with this Study Startup Specialist position:
- Clinical Trial Study Startup
- Site Activation
- IRB/IEC Submissions
- Regulatory Documentation
- Essential Document Collection
- Site Contract Negotiation
- Clinical Trial Budget Negotiation
- Investigational Product Coordination
- Clinical Study Supplies
- Ethics Committee Documentation
- Site Startup Timelines
- Vendor Coordination
- Clinical Operations
- Stakeholder Management
Benefits
According to the job posting, PSI CRO offers:
- Excellent working conditions
- Extensive training
- Supportive and friendly team environment
- Competitive salary and benefits package
- Opportunities for personal development
- Opportunities for professional and career growth
Salary for PSI CRO Study Startup Specialist II
PSI CRO has not disclosed an official salary range for this vacancy.
For structured job-search information, an estimated market range of approximately ₹6,00,000–₹10,00,000 per year may be considered for comparable study startup positions in India, depending on experience, skills, current compensation, and employer policies.
Note: This is an estimated range and should not be interpreted as an official salary offered by PSI CRO.
How to Apply
