CRA Line Manager

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

📋 Description

• Act as the primary contact for CRAs for non-project-specific inquiries.

• Oversee CRA performance and facilitate training and development opportunities.

• Engage with CRAs concerning knowledge, comprehension, compliance, project objectives, and both departmental and corporate goals.

• Strategize and execute resource solutions for new and ongoing projects in collaboration with the Resourcing team.

• Support the corporate strategy and vision aimed at organizational growth.

• Take part in the recruitment, interviewing, and hiring processes for CRAs.

• Facilitate new employee orientation and onboarding processes.

• Attend project-related meetings with Clinical Operations leadership.

• Ensure continuous evaluation of CRA performance, including the oversight of evaluation visits.

• Assist in formulating departmental quality standards and programs.

• Support the development and review of Clinical Operations SOPs/WIs.

• Cultivate and sustain professional relationships with both internal and external stakeholders.

• Review and authorize timesheets and discuss CRA utilization.

• Conduct monthly meetings with direct reports to evaluate workload, performance, deliverables, priorities, and compliance.

• Review and approve non-billable expenses.

• Initiate and manage Performance Improvement Plans for CRAs when necessary.

⛳️ Requirements

• Bachelor's degree in a Life Science field or equivalent experience.

• Proven experience in clinical research.

• Previous site monitoring experience, along with experience in managing CRAs.

• Comprehensive understanding of the drug development process, including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report preparation.

• Willingness to travel approximately 20% both domestically and internationally.

• Proficient in English.

🏝️ Benefits

• Collaborative, international team setting.

• Opportunities for career advancement.

• Flexible work arrangements including remote work options.

• Emphasis on work-life balance.

• Chance to engage in impactful clinical research that aids in delivering treatments to patients.

• Supportive culture built on trust and early ownership.

• Enthusiastic and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.