Remote, GBR
14 days ago
CRA Line Manager
+ 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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