Experienced Study Startup Specialist - Temporary position

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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.

You will mainly:

Lead finalization of site/vendor agreements and budgets negotiation to ensure alignment to the study activation plan
Customizes and prepare country- site-specific and vendor agreements and agreement amendments
Prepare and track the status of site and vendor agreements, budget negotiation, and coordinates the signature process

Additionally, you will:

Coordinates study startup activities with the local project team and supports all processes critical for site activation.
Collaborate with the project team for site activation processes
Assist in feasibility research and site identification
Collect site documents for IRB/IEC submission and/or IP-RED process
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
Train and coach department staff on startup processes

***Note, this is a temporary position for a period of 6-10 months***

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training & experience
2+ years of full-scope Study Startup experience in the country/region
Full working proficiency in Hebrew and English
Proficiency in MS Office applications
Ability to negotiate and build relationships at all levels
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Attention to detail, organizational and time-management skills

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.