CRA Line Manager

• The role of the Line Manager is to line manage CRAs and/or CTAs effectively, ensuring high
  performance, quality and continuous development. Including interviewing, evaluating and selecting
  CTAs and CRAs
• To assist in performing oversight in fulfilling its site management activities and obligations in
  relation to clinical studies as the primary sponsor of those studies.
• Create a culture of process improvement with a focus on streamlining processes adding value to our
  business and meeting the Sponsor's needs
• Travel (approximately 50%) domestic and international
• In addition to work according to and comply with relevant ICON/DOCS procedures and processes

Line Management Activities:

• Act as point of contact for Sponsor CTOM
• Manage key activities as needed to cover CRA/CTA absence
• Perform CRA accompanied visits within 3 months of CRA onboarding and routinely thereafter
  according to the Quality Oversight Plan
• Conduct activities detailed in the Quality Oversight Plan
• Interact with strategic partners (KOLs, Investigators and Site Staff) as necessary for execution of
  clinical trials and reinforcement of Sponsor's bran
• Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies,
  regulations and guidelines, including spot check review of reports and spot co-monitoring with CRAs
• Support FSP staff to achieve delivery of study objectives
• Supports CRAs with resolution of significant site issues and development of recruitment strategies
• Ensures that CRAs and CTAs are qualified and trained, both in clinical studies execution and in the Sponsor's policies and procedures, to provide data that meets quality requirements
• Provide leadership in the continuous improvement in CRA and CTA performance and monitoring
  processes
• Support staff with action plan development and resolution of findings from Clinical Quality Assurance
  audits
• Conduct resource planning and metrics review with sponsor site management
• Conduct staff regular performance assessments and personal/career discussions with direct reports
• Responsible for providing regular updates to Senior Management and adhering to metrics
• Review and approve itineraries, expense reports, and visit reports for assigned 
• Supervise IRB/IEC and Regulatory Authority Submission process if applicable
• Supervise administrative processes including document preparation, filing and archiving according to
  GCP and SOPs
• Supervise CRS related study start up process locally
• Supervise translation process
• Supervise eTMF process

Qualifications:

• Experience as CRA with LM potential as determined by hiring manager, CRA manager, project manager or equivalent job role
• Clinical trial processes and operations
• ICH/GCP Guidelines plus local codes of practice as applicable

Competencies:

• Attention to detail
• Organizational skills
• Relationship management & influencing skills
• Time management & prioritization
• Training skills
• Flexibility
• Written and oral communication skills
• Language skills: English
• Good working knowledge of common software packages
• Presentation skills
• Problem solver