Regional Clinical Study Manager

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

📋 Description

• Responsible for delivering regional studies with inspection-ready quality within the established timelines and budget.

• Lead the regional clinical operations team and supervise external partners.

• Serve as the escalation point for regional study challenges and ensure alignment with overall study objectives.

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

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

• Facilitate trial feasibility assessments, country allocation, and site selection.

• Coordinate local adaptations of global study documents and submissions to regulatory authorities and ethics committees/IRBs.

• Keep regional and country information up-to-date in study systems and tools.

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

• Ensure the creation, maintenance, and quality control of country and site-level Trial Master Files.

• Provide insights on regional drug inventories, labeling, regulatory approvals for comparator drugs, and reimbursement status.

• Oversee regional trial data collection, data entry, and query resolution.

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

• Monitor regional adherence to protocols, standard operating procedures, ICH/GCP guidelines, and applicable regulations.

• Prepare sites for quality assurance audits and inspections, ensuring inspection readiness.

• Drive responses to audit and inspection findings.

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

• Manage regional vendors, budgets, investigator fees, site payments, patient travel reimbursements, and resource requirements.

⛳️ 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 clinical operations experience.

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

• Demonstrated clinical research experience, including relevant team leadership experience in clinical functions.

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

• Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Capability to manage clinical study timelines, budgets, vendors, regulatory submissions, TMF quality control, and ICH/GCP compliance.

• Willingness to travel as necessary based on business needs.

🏝️ Benefits

• Travel may be required based on business needs.

• A higher degree is preferred.

• Opportunities for mentoring junior team members.