CRA Line Manager
ICON Clinical Research
+ The role of the Line Manager is to line manage CRAs and/or CTAs effectively, ensuring highperformance, quality and continuous development. Including interviewing, evaluating and selectingCTAs and CRAs
+ To assist in performing oversight in fulfilling its site management activities and obligations inrelation 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 ourbusiness 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 thereafteraccording 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 ofclinical 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 monitoringprocesses
+ Support staff with action plan development and resolution of findings from Clinical Quality Assuranceaudits
+ 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 toGCP 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
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