Requisition ID 14509BR
Title Manager, Field Management- New York, NY
Job Category Clinical
Job Description PURPOSE:
Responsible for the management and development of Clinical Research Associates (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 NNI. Accountable that the regional operating budget and operating margins to be managed in accordance with expectations, including expenses.
RELATIONSHIPS:
Reports to the Senior Manager/Associate Director/Director of Field Management (FM) or Director 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). 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.
ESSENTIAL FUNCTIONS:
BUDGET & CONTRACT COORDINATION:
- Ensuring regional operating budget is managed in line with organizational expectation, including expense management.
- Ensuring that the Field Management (FM) departmental spend is within the % target of agreed annual budget.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned region.
- Ensure that all regional personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure 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.
- 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.
DEPARTMENTAL MANAGEMENT AND STAFF DEVELOPMENT:
- Active mentorship of CTM staff to build talent across the department.
- Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of management of self and instill in all staff across CTM department.
FUNCTIONAL MANAGEMENT/SUPPORT:
- Accountable for the quality of CRA performance within assigned region responsible for the quality of CRA performance across the function.
- Cross team membership, coordination and motivation of the region across NNI.
- Implements and may participate in continuous improvement processes for function.
REGIONAL MANAGEMENT AND STAFF DEVELOPMENT:
- Active membership to local management teams.
- Direct supervision of assigned regional staff, including training, development, hiring, discipline, and terminations for them and the function. Ensures that standardized goals and objectives are implemented on corporate and local BSC targets.
- May provide support to functional or regional communication concerning organizational initiatives.
- May support the identification of training gaps within function or may provide support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the function or region.
- May support the maintenance of guidelines, training programs, policies and procedures for the functional locally. Approves vacation requests, meeting attendance, expense reports and check requests for staff.
- Responsible for the implementation and execution of strategies employed by the regional staff to meet corporate or local goals or directives.
- Responsible for ensuring proactive management of regional and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Director of FM as required based on impact at the core business. Providing guidance and oversight to junior staff on communication of such.
- Responsible for ensuring that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the function, 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.
- Responsible for ensuring 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.
REGIONAL MANAGEMENT:
- 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.
- Accountable for delivery of the productivity metrics for the assigned region, especially for trip report completion within the assigned timeframes and to the expectations of CTM.
REGIONAL OPERATING BUDGET AND RESOURCE ALLOCATION:
- Responsible for regional fiscal workload projections.
- Responsible for the assessment and allocation of resources for the region and reviews utilization data on a weekly basis to adjust and manage deployment proactively and effectively.
- Responsible for the coordination of CRA deployment, including integration within project teams, enabling clear understanding and action in relation to the CTM escalation pathway.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting for the region.
- Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations and that there clear understanding of expectations as a project team member from the function to ensure to the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible for maintaining focus, locally, for specific department activities within
CMR priorities.
- Supports the implementation of cross departmental work, locally, and communications for assigned as per the clinical development plans.
- Supports the implementation of cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
Additional Information TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support to training needs across CTM and direct the creation, development and
potentially provide training support to meet those needs.
PHYSICAL REQUIREMENTS:
- Approximately 50% overnight travel to provide one on one assessment of assigned regional staff.
- Minimal quarterly travel to Princeton, NJ.
- Must live within 100 miles of the regional workload center within assigned region.
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- Direct supervision assigned staff, including training, development, hiring, discipline, and terminations.
- Provides standardized goals and objectives to the function based on corporate and local BSC targets.
- Ensure staff are actively developed in the accordance with the departmental expectations.
- 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.
- 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.
- May develop and maintain guidelines, training programs, policies and procedures for the functional locally.
- Approves vacation requests, meeting attendance, expense reports and check requests for staff.
- May identify training gaps within region/function, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree required (science related discipline preferred).
- A minimum of 7 years of clinical trial experience within pharmaceutical, biotechnology or CRO company and/or healthcare setting, of which 5 years must be where the previous roles were directly related to clinical trial execution.
- A minimum of 12 months of on-site monitoring experience required.
- Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - FIELD MGMT NORTHEAST
Position Location US - Field Based - Across US
City New York
State/Provinces US - NY
Degree Required Bachelor's Degree Required
Percent Travel 50 - 60%
Title Manager, Field Management- New York, NY
Job Category Clinical
Job Description PURPOSE:
Responsible for the management and development of Clinical Research Associates (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 NNI. Accountable that the regional operating budget and operating margins to be managed in accordance with expectations, including expenses.
RELATIONSHIPS:
Reports to the Senior Manager/Associate Director/Director of Field Management (FM) or Director 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). 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.
ESSENTIAL FUNCTIONS:
BUDGET & CONTRACT COORDINATION:
- Ensuring regional operating budget is managed in line with organizational expectation, including expense management.
- Ensuring that the Field Management (FM) departmental spend is within the % target of agreed annual budget.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned region.
- Ensure that all regional personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure 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.
- 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.
DEPARTMENTAL MANAGEMENT AND STAFF DEVELOPMENT:
- Active mentorship of CTM staff to build talent across the department.
- Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of management of self and instill in all staff across CTM department.
FUNCTIONAL MANAGEMENT/SUPPORT:
- Accountable for the quality of CRA performance within assigned region responsible for the quality of CRA performance across the function.
- Cross team membership, coordination and motivation of the region across NNI.
- Implements and may participate in continuous improvement processes for function.
REGIONAL MANAGEMENT AND STAFF DEVELOPMENT:
- Active membership to local management teams.
- Direct supervision of assigned regional staff, including training, development, hiring, discipline, and terminations for them and the function. Ensures that standardized goals and objectives are implemented on corporate and local BSC targets.
- May provide support to functional or regional communication concerning organizational initiatives.
- May support the identification of training gaps within function or may provide support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the function or region.
- May support the maintenance of guidelines, training programs, policies and procedures for the functional locally. Approves vacation requests, meeting attendance, expense reports and check requests for staff.
- Responsible for the implementation and execution of strategies employed by the regional staff to meet corporate or local goals or directives.
- Responsible for ensuring proactive management of regional and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Director of FM as required based on impact at the core business. Providing guidance and oversight to junior staff on communication of such.
- Responsible for ensuring that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the function, 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.
- Responsible for ensuring 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.
REGIONAL MANAGEMENT:
- 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.
- Accountable for delivery of the productivity metrics for the assigned region, especially for trip report completion within the assigned timeframes and to the expectations of CTM.
REGIONAL OPERATING BUDGET AND RESOURCE ALLOCATION:
- Responsible for regional fiscal workload projections.
- Responsible for the assessment and allocation of resources for the region and reviews utilization data on a weekly basis to adjust and manage deployment proactively and effectively.
- Responsible for the coordination of CRA deployment, including integration within project teams, enabling clear understanding and action in relation to the CTM escalation pathway.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting for the region.
- Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations and that there clear understanding of expectations as a project team member from the function to ensure to the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible for maintaining focus, locally, for specific department activities within
CMR priorities.
- Supports the implementation of cross departmental work, locally, and communications for assigned as per the clinical development plans.
- Supports the implementation of cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
Additional Information TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support to training needs across CTM and direct the creation, development and
potentially provide training support to meet those needs.
PHYSICAL REQUIREMENTS:
- Approximately 50% overnight travel to provide one on one assessment of assigned regional staff.
- Minimal quarterly travel to Princeton, NJ.
- Must live within 100 miles of the regional workload center within assigned region.
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- Direct supervision assigned staff, including training, development, hiring, discipline, and terminations.
- Provides standardized goals and objectives to the function based on corporate and local BSC targets.
- Ensure staff are actively developed in the accordance with the departmental expectations.
- 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.
- 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.
- May develop and maintain guidelines, training programs, policies and procedures for the functional locally.
- Approves vacation requests, meeting attendance, expense reports and check requests for staff.
- May identify training gaps within region/function, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree required (science related discipline preferred).
- A minimum of 7 years of clinical trial experience within pharmaceutical, biotechnology or CRO company and/or healthcare setting, of which 5 years must be where the previous roles were directly related to clinical trial execution.
- A minimum of 12 months of on-site monitoring experience required.
- Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - FIELD MGMT NORTHEAST
Position Location US - Field Based - Across US
City New York
State/Provinces US - NY
Degree Required Bachelor's Degree Required
Percent Travel 50 - 60%