Manager, Clinical Monitoring (EU)

1 month ago
Full-time
Mid Level
Project and Program Management
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984

Description

  • Provide direct report/functional management for Clinical Research Associates (CRAs), meeting at least twice monthly to mentor, support development, and review performance.
  • Monitor CRA resource utilization, availability, realization, capacity for new work, and paid time off to maintain appropriate staffing levels.
  • Assess clinical monitoring resources and projections to ensure project teams meet client expectations and contractual obligations.
  • Report monthly on CRA staffing development, projections, gaps, accomplishments, metrics, and risks to Clinical Trial Operations leadership.
  • Support and perform CRA field assessments and periodic monitoring visits to evaluate GCP/ICH knowledge, compliance in practice, and sustained performance, incorporating input from project managers and CTLs.
  • Provide dynamic mentorship, serve as an escalation point and technical expert for employees and clients, and support professional development.
  • Collaborate with project teams to ensure customer satisfaction, high-quality deliverables, and profitability for clinical monitoring projects.
  • Determine required levels and types of clinical monitoring resources to meet corporate, client, and project objectives.
  • Interface across projects and functional areas, providing feedback to promote quality deliverables and participating in client presentations or bid defenses as needed.
  • Ensure staff adherence to policies, procedures, SOPs, ICH-GCP, and regulatory requirements and participate in quality improvement efforts and audits as requested.

Requirements

  • Bachelor’s degree in life sciences or a related field.
  • Minimum of 4 years of clinical monitoring experience in a CRO or pharmaceutical company.
  • Previous management experience is required.
  • Strong understanding of GCP, ICH guidelines, and EU regulatory requirements.
  • Proficiency in clinical trial management and monitoring processes.
  • Proven leadership and people management skills with experience mentoring and developing teams.
  • Ability to work collaboratively across functions and geographies.
  • Strong communication and interpersonal skills for liaison with internal teams and external stakeholders.
  • Demonstrated problem-solving skills with a proactive approach to addressing project challenges and competing priorities in a fast-paced environment.
  • Fluency in English required; additional EU language skills are a plus.

Benefits

  • Flexible work arrangements that support work-life balance and encourage employees to maintain life outside work.

Interested in this position?

Apply directly on the company website

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