PSI CRO is inviting applications for the position of Study Startup Specialist II in Bengaluru, Karnataka. This is a full-time, office-based opportunity for life sciences graduates with at least 2 years of full-scope study startup experience in India-based clinical trials.
The selected candidate will support country-level study activation, site agreements, regulatory submissions, clinical study documentation and coordination with investigational sites to ensure timely study startup.
Job Details
| Particulars | Details |
|---|---|
| Company | PSI CRO |
| Job Role | Study Startup Specialist II |
| Job Location | Bengaluru, Karnataka, India |
| Job Type | Full-time |
| Work Mode | Office-based |
| Qualification | College/University Degree in Life Sciences or equivalent |
| Experience | Minimum 2 years |
| Trial Experience | India-based clinical trials |
Position
– Study Startup Specialist II
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Job Responsibilities
- Collaborate with project teams to coordinate clinical trial site activation processes.
- Facilitate site agreements, contract negotiations and budget negotiations.
- Collect site documents for IRB/IEC submissions and IP-RED processes.
- Coordinate translation and review of study-specific documents.
- Identify and escalate project-specific issues.
- Prepare and submit study dossiers to sites, competent authorities and IRBs/IECs.
- Prepare IP-RED packages.
- Support the initial distribution of investigational products and clinical study supplies to sites.
- Coordinate information and documentation exchange with investigational sites, off-site facilities and vendors.
- Participate in developing site-specific startup timelines and enrolment projections.
- Ensure site activation targets are achieved.
Eligibility / Qualifications
Candidates applying for the PSI CRO Study Startup Specialist II position must meet the following criteria:
- College or university degree in Life Sciences, or an equivalent combination of education, training and experience.
- At least 2 years of full-scope Study Startup experience in India-based clinical trials.
- Full professional working proficiency in English.
- Ability to commute to the Bengaluru office daily.
Required Skills
- Clinical trial study startup and site activation.
- Site agreement and contract negotiations.
- Budget negotiation.
- IRB/IEC submission documentation.
- Clinical study dossier preparation.
- Investigational product distribution coordination.
- Strong communication and organizational skills.
- Negotiation and relationship-building abilities.
- Coordination with clinical research project teams, sites and vendors.
What PSI CRO Offers
- Excellent working conditions.
- Extensive training.
- Friendly team environment.
- Competitive salary and benefits package.
- Opportunities for personal and professional growth.
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