Job Detail

Description

Position Summary:

The Manager, Field CRA, is responsible for management and oversight of activities performed by a team of Field Clinical Research Associates based in Europe, who monitor and manage clinical sites for trials conducted by Seattle Genetics. This position focuses on training, supervision, and administrative oversight of direct reports. This is a highly collaborative role that interacts especially with other Regional Managers and Protocol Leads.  This role also contributes to process improvement and department initiatives. 

Principal Responsibilities:

People Management 

• Contribute to team recruitment: screen candidates for open positions and contribute to hiring decisions


• Train, develop, supervise and retain assigned team of Regional Field CRAs


• Onboard, coach, mentor, and advocate for direct reports in job responsibilities, company culture and career goals


• Identify training needs, formulate strategies to address training gaps, and conduct training


• Provide leadership and engagement, encourage innovation, maintain open communication and support for achieving company goals


• Evaluate performance, guide professional development, complete performance reviews and implement performance improvement plans as necessary
  
  
  
  • Regularly discuss and evaluate workload, metrics, and training compliance
  
  
  • Assess quality of trip reports and follow-up letters against the monitoring plan through periodic review
  
  
  • Obtain feedback on CRA performance throughout the year from PLs and other stakeholders
  
  
  • Conduct QC monitoring visits
  
  
  • Identify and escalate quality risks and issues, help prevent or correct deficiencies in performance of staff
  
  


• Ensure clinical trial study training records, CVs, Site Transitions Documents, QC reports, etc. are complete and maintained as required


• Ensure monitoring activities performed by the team are in compliance with CFR and ICH/GCP guidelines, relevant SOPs, and the Clinical Monitoring Plan

Department

• Support day to day operational activities of the Field CRA team in partnership with other line-managers, Protocol Leads, and CRAs


• Develop and maintain effective relationships with study and management teams to optimize feedback and collaboration


• Collaborate with PLs, Regional Managers to meet project resourcing needs, resolve potential resourcing conflicts, facilitate mutually beneficial resolutions and address study performance issues for clinical studies across assigned molecules


• Contribute to development, maintenance, and improvement of monitoring-related systems, processes and best practices for the Field CRA team including the onboarding plan


• Significantly contribute to department initiatives


• May serve as subject matter expert


• Help manage and solve challenging site and study issues or complex problems

 Qualifications:

• BA/BS, or equivalent, or relevant experience and training with a minimum of 8 years of pharmaceutical/biotech industry experience Advanced degree, RN or health care professional preferred


• Minimum of 5 years Monitoring experience is required, preferably in trials phase 1-3


• Oncology clinical research experience is required


• Proficiency in CFR and GCP/ICH required


• Experience working on global clinical trials is preferred


• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC, and eTMF)


• Experience managing people and teams involving different countries (direct or dotted-line reporting) is strongly preferred


• Able to proactively handle multiple tasks, manage a diverse range of functional activities, prioritize workload and solve problems simultaneously


• Strong leadership skills


• Able to plan, organize and lead clinical activities with minimum oversight


• Excellent communication and organizational skills


• A team player


• Able and willing to travel up to approximately 50%

 Education:

• BA/BS, or equivalent, or relevant experience and training with a minimum of 8 years of pharmaceutical/biotech industry experience Advanced degree, RN, or health care professional preferred