Study Startup Specialist II

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 professional 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 benefits 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 professional development and success.