Clinical Operations and Regulatory Affairs, Shanghai | 4 Oct 2021
CRA Line Manager (AD)
CRA Line Manager
Be responsible for CRA team management and operational management system.
Oversees the performance of the CRAs within their specified team. Implements professional development and performance evaluations;
Ensures that clinical monitoring activities of their assigned team are performed to the project’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;
Tracks clinical monitoring metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings;
Performs on-site Accompanied Site Visits with CRAs;
Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;
Assists with assessing and interviewing potential clinical monitoring candidates;
May conduct on-site monitoring visits to offer support to project teams;
May perform site visit report review and track site visit report metrics to ensure compliance;
May review and provide feedback on related SOPs and TOOLs during updates;
Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
Sc. in a field relevant to clinical research
Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry
Knowledge and skills
Excellent oral and written English skills.
Excellent line management skills
Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
Quick learner, good adaptability and versatile;
Excellent leadership, judgement and problem-solving skills;
Strong organizational, communication, time management and multi-tasking skills.