Sarah Knowles

Lead Clinical Project Manager @UCB

Responsible for leading multi-functional Clinical Trial Team(s) and coordinating and managing clinical studies. Responsibilities: Lead multi-functional Clinical Trial Team(s) working closely with the Early Clinical Lead, Program Delivery Manager and other team members as required. Coordinate and manage clinical studies including but not limited to: Tracking and management of budgets and timelines Providing clear, accurate and timely information flow and status updates internally and externally as required Selecting and managing vendors Ensure adequate participation, contribution and accountability of the study team members. Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices. Ensure that the study is audit/inspection ready at all times. Collaborate with members of Clinical Trial Team(s) and Clinical Sub-team to develop clinical trial protocol summary, protocols, Informed Consent Form/Patient Information and other trial documents (e.g. CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts). Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data, in collaboration with the Clinical Trial and the Clinical Sub-teams. Provide study specific training for internal and external (e.g. vendors, investigators) team members. Ensure appropriate response to new safety information (e.g. update of trial documents). Participate in clinical summary document generation (e.g. INDs, NDAs) and other submission activities for study specific issues, results or analysis and description of individual cases. Competences at expert level: Efficiency Verbal and Written Communication Skills Flexibility Interaction Influencing Innovation, Creativity and Focus on Excellence Managerial Courage (Decision Making and Risk Assessment) Customer Focus Quality-Minded Diplomacy Assertiveness Independence Building Teamwork Leadership