CRA Line Manager

Job not on LinkedIn

🔥 7 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Serve as the main point of contact for CRAs for non-project-specific needs • Manage CRA performance and support training and growth opportunities • Communicate with CRAs regarding knowledge, understanding, compliance, project goals, and departmental and corporate objectives • Plan and implement resource solutions for new and ongoing projects with the Resourcing team • Support corporate strategy and vision for organizational growth • Participate in CRA recruiting, interviewing, and hiring • Conduct new employee orientation and onboarding • Participate in project-related meetings with Clinical Operations leadership • Ensure ongoing evaluation of CRA performance, including monitoring evaluation visits • Assist in developing department quality standards and programs • Assist with Clinical Operations SOP/WI development and review • Build and maintain professional relationships with internal and external stakeholders • Review and approve timesheets and discuss CRA utilization • Conduct monthly calls with direct reports to assess workload, performance, deliverables, priorities, and compliance • Review and approve non-billable expenses • Initiate and oversee Performance Improvement Plans for CRAs as required

🎯 Requirements

• BA/BS in a Life Science field or commensurate experience • Demonstrated experience in clinical research • Prior site monitoring experience, including experience managing CRAs • In-depth knowledge of the drug development process, including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation • Ability to travel approximately 20% domestically and internationally • Fluent in English

🏖️ Benefits

• Collaborative, international team environment • Career growth opportunities • Flexible work arrangements / remote work • Work-life balance • Opportunity to contribute to meaningful clinical research that helps bring treatments to patients • Supportive culture with trust and early ownership • Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting

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