Clinical Research Manager

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 plan
• Enhance BeOne relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring

Delivery 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/resolution
• Ensures 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 requirements
• Supports site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issues
• Manages CRA adherence/compliance to SOPs and required training curricula

Management 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 monitoring
• Ensures CRAs have the required level of Monitoring area knowledge and skills to successfully deliver to protocol requirements
• Is responsible for managing and addressing CRA performance and quality performance indicators, including managing timely site activation, recruitment commitments, timely data entry and issue resolution

Budget 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) status
• Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis
• Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts
• Adheres to and contributes to the development and review of Working Instructions and SOPs, if required

Description 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 CRAs
• Provides necessary training to CRAs, support site visits as needed
• Performs CRA Assessment Visits and co-monitoring visits with CRAs if needed to ensure oversight and address site related concerns
• Assists with the identification of development opportunities for team members
• Conduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback as well as oversight of subordinate team’s performance