Job Description:
General Description:The Clinical Research Manager (CRM) is responsible for the hiring, training, competency development and assignment of CRAs to ensure qualified study implementation.
The CRM is responsible for CRA (trial monitoring and external) quality and compliance of clinical monitoring activities related to investigator site qualification, initiation, and trial conduct (recruitment, quality data collection, issue resolution and site management).
The CRM is responsible for CRA performance to KQI’s, ensuring implementation and appropriate application of established monitoring procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations.
The CRM is responsible for site engagement which is focusing on building relationship with study coordinator managers to identify site staff’s needs for the studies and establish positive company reputation.
Essential Functions of the job:
Allocation, initiation and conduct of trials
Allocate CRA resource in new trials in collaboration with Start-up and Clinical Monitoring teams.Ensures trial site selection, activation, enrolment, data flow and timeline commitments are delivered per established Monitoring KPI’s trial objectives.In collaboration with CSMs, reviews the status of planned versus actual patient recruitment and supports implementation of strategies to correct deviations from proposed planEnhance BeOne relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoringDelivery of quality data and compliance to quality standards
Is accountable for monitoring quality and issue resolution through timely review and support the approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation/resolutionEnsures CRA competency gaps are identified and resolved through targeted training curricula in collaboration with local trainer.Is responsible for execution of CRA Assessment visit to evaluate ongoing CRA monitoring competency, identifying issues and developing resolution strategies in collaboration with CSMs.Ensures adherence to clinical data standards, prevailing legislation, GCP, Institutional Review Board/Ethical Committee(IRB/EC) and SOP requirementsSupports site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issuesManages CRA adherence/compliance to SOPs and required training curriculaManagement of people and resources management
Is responsible for the hiring, training, development and retention of a team of CRAs to deliver quality monitoring to the Phase I-IV trials.Performs ongoing assessment and allocation of monitoring resources within study team to ensure balanced CRA workload for quality monitoringEnsures CRAs have the required level of Monitoring area knowledge and skills to successfully deliver to protocol requirementsIs responsible for managing and addressing CRA performance and quality performance indicators, including managing timely site activation, recruitment commitments, timely data entry and issue resolutionBudget and productivity
Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure within local targets for monitoring visits budget (as appropriate)Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) statusEnsures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basisReviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecastsAdheres to and contributes to the development and review of Working Instructions and SOPs, if requiredDescription for focusing on Japan:
Supports Senior Director to build Japan organization and required process such as Local SOP and WI. Conducts Country level feasibility. Supports country activity for new studies until regional/ country CSM is identified. Vendor management for FSP partners and dispatching staffs in Japan. Takes trial management responsibility if required. Conducts Site Motivation visits and Site Engagement Visit in Japan. Prepares and supports PMDA inspection Other tasks, if needed. Supervisory Responsibilities:
Provides mentoring and oversight of team members and CRAsProvides necessary training to CRAs, support site visits as neededPerforms CRA Assessment Visits and co-monitoring visits with CRAs if needed to ensure oversight and address site related concernsAssists with the identification of development opportunities for team membersConduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback as well as oversight of subordinate team’s performanceQualification Required:
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Education Required:
Bachelors degree or higher in a scientific or healthcare discipline preferredA minimum of 5-6+ years of relevant clinical operations experience.Other Qualifications:
Associate CRM: 1-3 years of people management or project management in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant fieldCRM: 3 years or above of people management and project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant fieldSenior CRM: 5 years or above of people management and project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant fieldCRM/Senior CRM: Solid understanding of career development and performance management activitiesDocumented training, knowledge and application of current Regulations, GCP and ICH guidelines in clinical trials requiredEvidence of team leadership capabilitiesTherapeutic or medical knowledge preferredExhibits a strong understanding of methodologies and approachesUnderstanding of all aspects of monitoring and trial executionExcellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, local/National Health Authorities regulations and BeiGene standardsStrong written and verbal communicate effectively with site personnel, country and global associatesComputer skills including proficiency in use of Microsoft office,Excellent organization skill and management of competing priorities Travel: up to 30-40% time, as required
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus schemeCompany shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunitiesFantastic benefits program and keep improving!Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.Join us and Make momentum in your career!BeOne Global Competencies
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