Job Description

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

This is an office-based position from our Bangalore office.

You will:
Collaborate with the project team for site activation processes
Facilitate site agreement, contract negotiations and budget negotiations
Collect site documents for IRB/IEC submission and/or IP-RED process
Coordinate translation and review of study-specific documents
Identify and escalate project-specific issues as needed
Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
Prepare IP-REDs packages
Support initial distribution of Investigational Product(s) and clinical study supplies to sites
Ensure exchange of information and documentation with investigational sites, off site facilities and vendors




Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets

Qualifications
College/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 trials
Full skilled working proficiency in English
Well-developed communication and organizational skills
Ability to negotiate and build relationships at all levels

Additional Information

We offer:
Excellent working conditions
Extensive training and friendly team
Competitive salary and perks package
Opportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their career development and success.

📌 Study Startup Specialist Ii Bengaluru
🏢 Psi Cro
📍 Bengaluru