Site Management Associate (SMA) at PSI CRO

Raanana, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Management, Document Management, TMF Oversight, Clinical Trial Management, CTMS, EDC, Regulatory Submissions, Vendor Management, Clinical Supplies Management, MS Office, Interpersonal Skills, Problem Solving, Organization, Planning, Multi-tasking, Customer Service

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 Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. You will focus on facilitating research projects of novel medicinal products, while taking a step further in your professional career. Office-based role in Ra'anana, Israel The scope of responsibilities will include: Performs site management activities, documents and trackers management, and communication with the sites and study vendors. Site Management and Communication Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies Ensures regulatory and ethics committee submissions and notifications Ensures proper administration of sites and vendors payments, as applicable Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings Maintains study-specific and corporate tracking systems Document Management Maintains Trial Master File and performs TMF oversight at country/site level Prepares, distributes, and updates Investigator Site Files and ISF checklists Revises and checks translation status Safety Management Ensures proper safety information flow with investigative sites CTMS Management Updates CTMS with project information Supports Monitors in completion of all subject and site events information in CTMS, and meeting deadlines for site visits and visit reports Qualifications College/University Degree (Life Sciences) Prior administrative experience in Clinical Research / CRO environment, preferably in an international setting Full working proficiency in Heberw and good English skills Proficiency in standard MS Office applications (Word, Excel and PowerPoint) Good organizational and planning skills, problem-solving abilities, flexibility Detail-oriented, able to multi-task and work effectively in a fast-paced environment Team-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects *Please send your CV in English Additional Information As a privately owned mid-size CRO, we are constantly growing, offering plenty of opportunities for personal and professional growth. Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you: Excellent and flexible working conditions A unique combination of team collaboration and independent work 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 a company that focuses on its people and invests in their professional development and success. Do you want to make a difference? | | Discover PSI. - PSI CRO Recruitment Brochure

Responsibilities

The role involves performing site management activities, managing documents and trackers, and facilitating communication between investigative sites and project teams. Key duties include maintaining the Trial Master File (TMF), managing clinical supplies, and updating the Clinical Trial Management System (CTMS).