Regional Clinical Study Manager

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

📋 Description

• Responsible for the delivery of regional studies with the required quality for inspection readiness, adhering to established timelines and budgets.

• Lead the regional clinical operations team along with external partners.

• Serve as the escalation point for any regional study-related issues.

• Collaborate with regional stakeholders and communicate study progress updates to senior management and the Global Clinical Study Manager.

• Represent the regional study team during internal and cross-functional Clinical Study Team meetings.

• Oversee the planning and management of assigned clinical studies from feasibility through to closeout.

• Manage timelines for study start-up and recruitment, while tracking regional progress.

• Drive trial feasibility assessments, country allocations, and site selections for the designated region.

• Ensure prompt local adaptation and submission of global study documentation.

• Maintain regional and country-specific information in study management systems and tools.

• Collaborate with Clinical Research Associates (CRAs) to ensure effective site execution and review/sign off on monitoring reports.

• Guarantee that Trial Master Files at the country and site level are established, maintained, and subject to quality control.

• Provide insights on regional drug inventories, local drug labeling, comparator drug approvals, and reimbursement status.

• Manage the collection of regional trial data, data entry, and resolution of queries.

• Assist in the planning and execution of Clinical Study Reports.

• Address escalated site issues and ensure compliance with protocols, SOPs, ICH/GCP, and applicable regulations.

• Ensure readiness for regional inspections and prepare sites for audits and inspections.

• Share insights and best practices to enhance study efficiency and quality.

• Contribute to the development and review of work instructions and SOPs.

• Select and oversee regional study vendors while managing regional study budgets.

• Coordinate activities related to investigator fees, site payments, and patient travel reimbursements.

• Identify regional resource requirements, establish contingency plans, and monitor resource utilization.

• Provide performance feedback and mentor junior team members.

⛳️ Requirements

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

• A higher degree is preferred.

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

• A minimum of 4 years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO industries.

• Demonstrated clinical research experience, including relevant experience as a team lead in clinical functions.

• Experience as a Clinical Research Associate (CRA) is preferred.

• Proficient in computer skills: MS Office and Project Planning Applications.

• Familiarity with study protocols, SOPs, ICH/GCP, and pertinent regulations.

• Capable of managing regional study vendors, budgets, resources, timelines, submissions, and data collection.

• Willingness to travel as required by business needs.

🏝️ Benefits

• Salary range of 291,400 - 364,200 RON.

• Travel may be required based on business needs.

• Commitment to equal opportunity employment.