BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.Identify gaps and areas for improvement and propose CAPA.Supports start-up and provides local expertise.SSU experience is considered a plusPerform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targetsProvides protocol and related study training to assigned sites.Conducts pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPsConducts co-monitoring visits, if requiredCompletes monitoring visit reports in accordance with ICH-GCP, BeiGene standards and SOPManages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolutionEstablish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical OperationsEnsure inspection readiness of the study and sitesCollaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)Attends disease indication project specific training and general CRA training as requiredFacilitate Study Oversight Visits (SOVs), site audits and/or inspections, as requiredEvaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities.Constantly strive for operating excellence, question status-quo and promote innovation.Mentor and manage junior staff and Clinical Research AssociatesActs as the escalation point person for CRA(s) with site related issues and concernsMay review visits reports, following-up on issue resolution and communicating with the Regional Clinical Operations Manager on significant risk identified and action proposedMay serve as subject matter expert for clinical operations, country regulations and monitoring related activities.Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookOther Qualifications:Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelinesAt least 3 years of (CRA) monitoring experience in the pharmaceutical or CRO industryExperience in oncology/hematology trials preferredExcellent communication and interpersonal skillsExcellent organizational skills and ability to prioritize and multi-taskFluent in English & Italian (writing and speaking)Education Required:BS in a relevant scientific discipline and minimum of 3 years of monitoring experience.Experience in oncology global trials preferredTravel: up to 60%Competencies: Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently.Completes administrative tasks correctly and on time.Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.Writes clearly and informatively.Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.Contributes to building a positive team spirit; Shares expertise with others.Adaptability – Able to adapt to changes in the work environment.Manages competing demands.Changes approach or method to best fit the situation.Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.Project Management - Communicates changes and progress; Completes projects on time and budget.BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity
