Manager, Clinical Monitoring

2 giorni fa

Roma, Italia Rho A tempo pieno

We're a proud bunch of science nerds who love tackling big challenges together. What You'll Be Doing Direct report / functional management responsibilities for CRAs; Maintain retrospective and prospective vigilance of utilization, realization, availability to take on additional work and paid time off
Support the assessment of clinical monitoring employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations
Report monthly on CRA staffing development progress, projections, gaps and potential needs, highlighting key areas of accomplishments, metrics and risks
Perform periodic monitoring field assessment visits of CRAs to assess GCP/ICH knowledge and compliance in practice and to ensure continued level of optimal performance. Supplement assessments by proactively seeking input from appropriate project managers and CTLs as to project-specific performance
Provide dynamic mentorship in all aspects of clinical monitoring; Collaborate with project teams to ensure customer satisfaction, high quality deliverables, and profitability for all clinical monitoring projects
Determine level and type of clinical monitoring employee resources needed to meet corporate/client/project objectives
Interface with staff across projects and functional areas, providing input and feedback to promote quality deliverables
May participate in Sponsor and Regulatory Authority audits as requested by Quality Assurance (QA)
Ensure staff fulfills their responsibilities in accordance with policies, procedures, SOPs, ICH-GCPs, and regulatory requirements
Participate in quality efforts for continuous improvement by assuring quality metrics are in line with company, client and clinical operations objectives
Bachelor's Degree in life sciences or a related field, along with a minimum of 4 years of clinical monitoring experience in a CRO or pharmaceutical company; previous management experience preferred.
Strong understanding of GCP, ICH Guidelines, and regulatory requirements within the EU.
Proficient in clinical trial management and monitoring processes.
Excellent leadership and people management skills with a proven ability to mentor and develop talent within teams.
Demonstrated problem-solving abilities with a proactive approach to addressing project challenges.
Fluency in English is required; additional language skills relevant to EU countries are a plus.
Mid-Senior level
Full-time

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