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.
