CRA Line Manager
PRA Health Sciences
Req #: 121768
Type: United Kingdom
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Overview: * 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 Responsibilities: 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: 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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