KATHLEEN PATERNOSTER

- Provides leadership, direction and management to Clinical Operations staff in the FSP BU.

- Provides training, consultation and oversees quality related for operating activities of assigned staff to ensure project deliverables are met.

- Acts as primary point of contact for resourcing escalations, assuring utilization, performance and development of Clinical Operations staff.

- Liaise with other departments or business units to optimize resources as well as to establish harmonize clinical operations practices, processes and tools.
- Line Management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff, including the management and development of other Clinical Operations line managers. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
- Liaise with Resourcing management on active awarded and proposal project assignments. Review workload for all staff in reporting chain. Manage the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
- Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metrics compliance, and development of contingency plans, among others. Analyze performance and quality metrics and compliance metrics. Address improvement initiatives as identified.
- Support the assessment of overall regional Clinical Operations staff growth and actively participate in the selection and hiring process. Proactively works to ensure staff retention and turnover rates remain within expected levels.
- Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP. Ensures all staff follows required training and completes the required documentation. Provides regular compliance updates to management accordingly.
- Oversees progress of teams supporting clinical projects. Ensures individual and team tasks are completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract. Support the management of customer relationships, and escalate more serious issues as required.
- Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors. Ability to develop and oversee, and provide direction to more junior managers in their reporting line, in the development of training plans and formal performance management plans for individuals to address performance deficiencies, when necessary.
- Identify needs and may make recommendations for process improvement and efficiencies.

Line management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and employee counseling for staff. May be involved in assignment of project work and will review workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
Participate in managing the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively works to ensure staff retention and turnover rates remain within expected levels.
Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs. Ensures all staff follows required training and completes the required documentation. Provides regular updates to management accordingly.
Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors. Able to contribute to BU level process improvements. May provide business development support.
May conduct various types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensures staff adheres to training guidelines, training records are maintained and individual and corporate training needs are identified and addressed.
Organizes and chairs clinical staff meetings at regular intervals. Manages issues and provides follow up for action items requiring resolution.

The Clinical Operations Lead (COL) is accountable for the delivery of clinical monitoring aspects of all assigned projects: on or ahead of time, on or under budget, high quality data and reports, in compliance with all applicable regulations and Sponsor requirements. For any specific study assignment, the COL will liaise with, report to and deliver clinical study status for the clinical monitoring part to the study Project Manager.
The COL is also involved in line management activities which includes onboarding of new hires, oversight of training, compliance, performance and career management, and development of direct reports.

Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations. Provides clinical and technical support for CRA I, CRA II and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).
Works as Lead CRA on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader.

Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations. Provide clinical and technical support for CRA I and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).

Completes project activities associated with monitoring functions of Phase III studies.

Responsible for monitoring visits and close out visits for international multi-centre phase IV trials in the field of psychiatry.

Responsible for completion of in-house project related work (ethical committee submissions, investigational product tracking records, investigator site file setup).

Responsible for monitoring visits and close out visits for international multi-centre phase IV trials in the field of psychiatry.