Regional Clinical Trial Management Associate

This is a fully remote position, open to applicants in Italy.

📋 Description

• Assist the Regional Clinical Study Manager in the delivery of regional studies, ensuring that delegated clinical study components adhere to quality, timeline, and budgetary expectations.

• Aid in feasibility assessments, study initiation, document generation and review, sample tracking, and participant enrollment.

• Interpret and apply clinical research regulations and ICH guidelines effectively.

• Facilitate the setup and logistics of regional team meetings.

• Collaborate with the Regional Clinical Study Manager, Global Study Management Associate, CRAs, and both regional and global stakeholders.

• Prepare materials for monitoring visits and organize documents in the Trial Master File (TMF).

• Create and manage regional/country SharePoint folders and study distribution lists.

• Establish and maintain countries and sites within eTMF, CTMS, and other relevant systems.

• Assist with system access requests and the management of user accounts.

• Support local adaptations and reviews of study-related documents.

• Facilitate regional/country study start-up and investigator meetings.

• Create, maintain, review, and perform quality checks on country/site-level TMF documents.

• Address regional/country clinical supply challenges in collaboration with stakeholders.

• Assist in data cleaning and follow up on outstanding information.

• Prepare site newsletters and correspondence related to the study.

• Provide support for routine inquiries from clinical trial sites.

• Help maintain regional/country information in public registries such as ClinicalTrials.gov.

• Supply regional/country data for Clinical Study Reports.

• Assist in identifying operational risks, conducting quality assurance audits, inspections, and process improvements, as well as maintaining local/regional tools, work instructions, and SOPs.

• Support the setup of regional vendors and manage regional study budgets and purchase orders.

⛳️ Requirements

• A Bachelor’s Degree in a scientific or healthcare field is required.

• A higher degree is preferred.

• Exceptions may be considered for candidates with relevant experience in clinical operations.

• Proficiency in MS Office is required.

• Knowledge of clinical operations methodologies and an understanding of the operational aspects of clinical study processes are essential.

• A minimum of 1 year of experience in clinical research within the biotech, pharma, or CRO industry is necessary.

• Some travel may be required.

🏝️ Benefits

• Competitive salary and benefits package.

• Opportunities for professional development and career advancement.

• Collaborative work environment with a focus on innovation.