Site Management Associate

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion • Serve as the primary site’s contact point for vendors, study supplies, and access management • Ensure that pre-study testing of local site facilities is completed • Assists the Monitors in their prompt completion of all subject event and site event information in CTMS • Track the resolution status of site issues and action items in CTMS • Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies • Ensure regulatory and ethics committee submissions and notifications • Coordinate preparation for and follow-up on site, TMF and systems' audits and inspections • Manage the TMF on a site and a country level for regularly and file documents • Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists • Arrange and track initial and ongoing project training for site teams in all vendor-related systems • Document Management and translations status review of the study

🎯 Requirements

• College/University Degree in Health Sciences • Administrative work experience • Prior experience working in Clinical Research • Local regulations knowledge • Full working proficiency in English and Portuguese • Proficiency in MS Office applications • Ability to plan and work in a dynamic team environment • Communication and collaboration skills

🏖️ Benefits

• Professional development • Remote work options