Study Startup / Site Activation Specialist - Temporary position at PSI CRO

Raanana, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

09 May, 26

Salary

0.0

Posted On

08 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Startup, Site Activation, Agreement Negotiation, Budget Negotiation, IRB/IEC Submission, Competent Authorities Submission, Investigational Product Distribution, Timeline Development, Enrolment Projections, Staff Training, Problem-Solving, Organizational Skills, Time-Management, Collaboration, Multitasking, Relationship Building

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The specialist will lead the finalization of site/vendor agreements and budget negotiations to align with the study activation plan, customizing necessary country-site-specific documents. Additionally, they will coordinate all study startup activities with the local project team to ensure smooth and timely site activation processes.