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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Support
Job Category:
Professional
All Job Posting Locations:
Kibbutz Shefayim, Center District, Israel
Job Description:
The Associate Site Manager is a role that serving as the primary liaison between the sponsor and investigational sites. This position ensures inspection readiness and compliance with clinical trial protocols, SOPs, Good Clinical Practice (GCP), and applicable regulations from study start-up through site closure. The role involves collaboration with Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) to support site management activities including site initiation, monitoring (on-site and remote), and close-out.
Key Responsibilities:
- Act as the primary contact for assigned sites, ensuring compliance and inspection readiness.
- Participate in site feasibility and qualification visits; attend investigator meetings as needed.
- Support site initiation, start-up, monitoring, and close-out activities according to SOPs and regulatory requirements.
- Implement risk-based monitoring models and ensure timely resolution of site issues.
- Ensure site staff training and maintain accurate training records throughout all trial phases.
- Collaborate with study teams to accelerate site activation and recruitment strategies.
- Manage investigational product and study supplies, including handling, storage, returns, and destruction.
- Ensure timely and accurate data entry, query resolution, and documentation of trial activities.
- Report and document Adverse Events (AEs), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs) within required timelines.
- Maintain essential documents and systems; prepare visit reports and follow-up letters.
- Participate in audits, CAPA implementation, and process improvement initiatives.
- Build and maintain strong relationships with investigators, trial coordinators, and site staff.
Requirements:
- Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
- Experience: 0-2 years in clinical research or site management (entry-level).
- Knowledge:
- Basic understanding of GCP and clinical trial regulations.
- Familiarity with clinical trial protocols and site operations.
- Skills:
- Strong organizational and time management skills.
- Ability to work independently and collaboratively in a team environment.
- Excellent communication and interpersonal skills.
- Attention to detail and accuracy in documentation.
- Technical:
- Proficiency in MS Office and ability to learn clinical trial management systems.
- Other:
- Willingness to travel to investigational sites as required.
- Ability to maintain compliance and inspection readiness.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management
