Study Startup Specialist II

Study Startup Specialist II

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

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. 

You will: 

• Perform study startup activities and support all processes critical for site activation
• Collect site documents for IRB/IEC submission and/or IP-RED process
• File study-specific documentation in TMF, in accordance with Document management plan
• Assist in feasibility research and site identification, upon request
• Facilitate site agreement and budget negotiations
• Coordinate translation and review of study-specific documents
• Identify and escalate project-specific issues as needed
• Prepare and submit IP-REDs packages
• Ensure initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained 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 under supervision

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 the country/region
• Full 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.