Requisition ID 14537BR
Title Manager, Site Management
Job Category Clinical
Job Description PURPOSE:
Responsible for the management and development of Site Management staff in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for operational aspects of planning and management of performance in accordance with departmental productivity expectations. Close collaboration with other managers within CTM and with various functional units of NNI. Accountable that the operating budget and operating margins to be managed in accordance with expectations, including expenses.
RELATIONSHIPS:
Reports to the Associate Director of Site 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 Business Support Coordinators, Clinical Trial Coordinators, In-house Clinical Research Associates (IH CRAs, Site Specialists and/or Lead CRAs. Effectively manages to the direction and strategy for 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 operating budget is managed in line with organizational expectation, including expense management.
- Ensuring that the Site Management (SM) 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 staff.
- Ensure that all personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.
- Ensure that all 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 staff performance and responsible for the quality of performance across the function. Will be accountable to assess monitoring performance of assigned staff as applicable.
- 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 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 support and communicate functional, departmental or organizational initiatives.
- May support the identification of training gaps within function or assigned personnel, 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 or assigned staff.
- 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 staff to meet corporate or local goals or directives.
- Responsible to ensure proactive management and collaboration on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Associate Director of SM 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. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for performance 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, especially for trip report completion within the assigned timeframes and to the expectations of CTM.
REGIONAL OPERATING BUDGET AND RESOURCE ALLOCATION:
- Responsible for fiscal workload projections.
- Responsible for the assessment and allocation of resources and reviews utilization data on a monthly basis to adjust and manage deployment proactively and effectively.
- Responsible for the coordination of I-H 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 assigned personnel.
- May support the implementation cross departmental work, locally, and communications for assigned as per the clinical development plans.
- May support the implementation cross departmental work, locally, and communications for assigned as per the clinical development plans.
- 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.
Additional Information TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary.
- Provide support to needs across CTM and direct the creation, development and potentially provide training support to meet those needs.
PHYSICAL REQUIREMENTS:
- Approximately 10-20% overnight travel
- Office Based- Princeton, NJ
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 (in science area preferred).
- A minimum of 7 years of clinical trial experience within pharmaceutical and/or healthcare setting. 5 years within a pharmaceutical, biotechnology or CRO where the previous roles were directly related to clinical trial execution is preferred.
- 12 months of site monitoring experience strongly preferred.
- 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).
- Knowledge of GCP as relates to clinical trial management.
Department CMR - SITE MANAGEMENT (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Title Manager, Site Management
Job Category Clinical
Job Description PURPOSE:
Responsible for the management and development of Site Management staff in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for operational aspects of planning and management of performance in accordance with departmental productivity expectations. Close collaboration with other managers within CTM and with various functional units of NNI. Accountable that the operating budget and operating margins to be managed in accordance with expectations, including expenses.
RELATIONSHIPS:
Reports to the Associate Director of Site 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 Business Support Coordinators, Clinical Trial Coordinators, In-house Clinical Research Associates (IH CRAs, Site Specialists and/or Lead CRAs. Effectively manages to the direction and strategy for 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 operating budget is managed in line with organizational expectation, including expense management.
- Ensuring that the Site Management (SM) 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 staff.
- Ensure that all personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted.
- Ensure that all 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 staff performance and responsible for the quality of performance across the function. Will be accountable to assess monitoring performance of assigned staff as applicable.
- 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 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 support and communicate functional, departmental or organizational initiatives.
- May support the identification of training gaps within function or assigned personnel, 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 or assigned staff.
- 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 staff to meet corporate or local goals or directives.
- Responsible to ensure proactive management and collaboration on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Associate Director of SM 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. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for performance 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, especially for trip report completion within the assigned timeframes and to the expectations of CTM.
REGIONAL OPERATING BUDGET AND RESOURCE ALLOCATION:
- Responsible for fiscal workload projections.
- Responsible for the assessment and allocation of resources and reviews utilization data on a monthly basis to adjust and manage deployment proactively and effectively.
- Responsible for the coordination of I-H 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 assigned personnel.
- May support the implementation cross departmental work, locally, and communications for assigned as per the clinical development plans.
- May support the implementation cross departmental work, locally, and communications for assigned as per the clinical development plans.
- 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.
Additional Information TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary.
- Provide support to needs across CTM and direct the creation, development and potentially provide training support to meet those needs.
PHYSICAL REQUIREMENTS:
- Approximately 10-20% overnight travel
- Office Based- Princeton, NJ
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 (in science area preferred).
- A minimum of 7 years of clinical trial experience within pharmaceutical and/or healthcare setting. 5 years within a pharmaceutical, biotechnology or CRO where the previous roles were directly related to clinical trial execution is preferred.
- 12 months of site monitoring experience strongly preferred.
- 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).
- Knowledge of GCP as relates to clinical trial management.
Department CMR - SITE MANAGEMENT (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%