Requisition ID 45681BR<br/>Title Senior Manager, Field Management- Dallas<br/>Job Category Clinical Trial Management<br/>Job Description Purpose<br/>Responsible for the management and development of CRAs within assigned region in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for regional operational aspects of planning and management of monitoring performance in accordance with departmental productivity expectations. Close collaboration with other CRA managers and with various functional units of Clinical Trial Management (CTM). Accountable that the regional operating budget and operating margins to be managed in accordance with expectations, including expenses.<br/><br/>Relationships<br/>Reports to the Head of Field Management within Clinical Trial Management (CTM). Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of all functional and departmental milestones. Reporting to this position are Clinical Research Associates (CRAs) and Managers of Field Management. Effectively manages to the direction and strategy for monitoring performance within clinical trials at NNI thereby facilitating the CTM department to effectively manage all its business deliverables. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.<br/><br/>Essential Functions<br/>BUDGET & CONTRACT COORDINATION:<br/>• Ensures regional operating budget is managed in line with organizational expectation, including expense management.<br/>• Ensures that the Field Management (FM) departmental spend is within the % target of agreed annual budget.<br/>COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:<br/>• Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned region.<br/>• Ensures that all regional personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.<br/>• Ensures that all regional personnel understand the priorities of the business, that they are focused on those priorities and that their level of accountability is understood and accepted.<br/>• Responsible for the coaching, development and growth leading directly to improvement of talents of the personnel within the assigned region to meet increasing levels of responsibility.<br/>FUNCTIONAL MANAGEMENT & STAFF DEVELOPMENT:<br/>• Accountable for the quality of CRA performance within assigned region and responsible for the quality of CRA performance across the function.<br/>• Active membership on local management teams.<br/>• Active mentorship of CTM staff to build talent across the department.<br/>• Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way, and instills in all staff across CTM department.<br/>• Cross team membership, coordination and motivation of the region across NNI.<br/>• Implements, and may participate in, continuous improvement processes for function.<br/>REGIONAL MANAGEMENT & STAFF DEVELOPMENT:<br/>• May identify training needs within function or region, support the development of training materials to meet those needs, and provide training as required to improve core competency and skill set of the department.<br/>• May provide input and maintain guidelines, training programs, policies and procedures for the function locally. Approves vacation requests, meeting attendance, and expense reports.<br/>• May provide input, support and communicate functional, departmental or organizational initiatives.<br/>• Responsible for the implementation and execution of strategies employed by the regional staff to meet corporate or local goals or directives.<br/>• Responsible to ensure proactive management of regional staff and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the head of FM as required based on impact at the core business. Provide guidance and oversight to junior staff on communication of such.<br/>• Accountable for all timelines and effective resource deployment across the assigned region. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for monitoring performance for the assigned region and ensures this is integrated into the overall plan for the monitoring management functional and departmental CTM business deliverables plan.<br/>• Accountable for delivery of the productivity metrics for the assigned region, especially for monitoring visit report completion within the assigned timeframes and to the expectations of CTM.<br/>REGIONAL OPERATING BUDGET & RESOURCE ALLOCATION:<br/>• Responsible for regional fiscal workload projections.<br/>• Responsible for the assessment and allocation of resources for the region and reviews utilization data on a monthly basis to adjust and manage deployment proactively and effectively.<br/>• Responsible for the coordination of CRA deployment, including integration within project teams, enabling clear understanding and action in relation to the CTM escalation pathway.<br/>TEAM COORDINATION:<br/>• Accountable for the compliance and quality of CATS reporting for direct reports.<br/>• Implements cross departmental work, locally, and communications for assigned as per the clinical development plans.<br/>• Implements work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR.<br/>• Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure, that appropriate updates are provided, that performance is to their expectations, and that there is a clear understanding of expectations as a project team member from the function to ensure the success of a matrix management structure.<br/>• Responsible for ensuring that the mandatory trial entries are made in IMPACT, novoDOCs, EDC, and other related systems as per requirements.<br/>• Responsible for maintaining focus, locally, for specific department activities within CMR priorities.<br/><br/>TRAINING:<br/>• Attends relevant symposia, conferences, and scientific meetings, as necessary.<br/><br/>Physical Requirements<br/>• 40-50% overnight travel required<br/>• Must live within 100 miles of the regional workload center within assigned region.<br/>Additional Information Development of People<br/>• Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.<br/>• Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.<br/>• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.<br/><br/>Qualifications<br/>• A Bachelor’s degree required (in science related discipline preferred).<br/>• A minimum of 1 year of on-site monitoring experience required.<br/>• A minimum of 10 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting required.<br/>• A minimum of 3 years’ prior supervisory, project management or leadership experience required.<br/>• Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level.<br/>• Demonstrated computer skills (MS Office, MS Project, MS PowerPoint).<br/>• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.<br/>• Knowledge of GCP as it relates to clinical trial management.<br/>Department CMR - FIELD MGMT CENTRAL (1)<br/>Position Location US - Field Based - Across US<br/>City Dallas<br/>State/Provinces US - TX
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