Provides leadership, direction and management to Central Monitoring Specialist and Risk Managers. Provides training, consultation and oversees quality related for operating activities to ensure project deliverables are met.
Acts as primary point of contact for risk-based monitoring strategy and alignment both internally and externally. May liaise with other departments or business units to optimize resources as well as to harmonize central monitoring and clinical operations practices, processes and tools.
Contributes to operational initiatives and continuous improvement. Participates in industry events related to risk-based management and monitoring.
Will be responsible for acting as primary point of contact for key accounts in developing an agreed monitoring strategy across a portfolio of projects.
Analyzes compliance and quality of services to ensure clinical operations / central monitoring delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures.
Participates in the financial review of project status and drives project financial performance, particularly as related to clinical operations / central monitoring services.
Provides expert risk-based monitoring strategy, oversight and guidance to support internal teams and sponsors.
Guides internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient RBM / IQRM solution.
Where sponsors desire to incorporate new data sources, technologies or new / supplemental / substitute processes to support RBM, strategizes with internal team members and sponsors to agree on "hybrid" approach that is efficient and effective.
Works with internal team members and sponsors to ensure access to data needed to execute RBM according to the agreed plan.
Provides expert operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others.
Analyzes performance and quality metrics to assure BU achievement of quality and compliance expectations related to patient safety and data integrity as well as RBM success measures.
Functions as point of escalation for central monitoring / RBM / IQRM issues. Oversees progress of teams supporting clinical projects.
Ensures individual and team tasks are completed according to requirements per Sponsor / Customer expectations and contract.
Leads work streams to support the development and implementation of new initiatives and strategic direction of the BU, cross-BU Clinical Operations and cross-functionally.
Address improvement initiatives as identified.
Ensures quality and adherence to Standard Operating Procedures / Work Instructions (SOP / WI) and compliance with federal and local guidelines and ICH GCP.
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.
Develops and supports customer relationships, manage customer expectations and escalates more serious issues as required.
Works closely within appropriate business unit / region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors.
Identifies needs and may make recommendations for process improvement and efficiencies.
Participates in committees and work groups to support the development and implementation of new initiatives and strategic direction of the BU and cross-BU Clinical Operations.
May provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required.
May participate in marketing activities, client presentations and proposal development.
Line Management of Central Monitoring Specialists and Risk Managers, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring / counseling of staff.
Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
Liaises with resourcing management on active awarded and proposal project assignments.
Reviews workload, utilization, productivity, and quality for staff in reporting chain.
Manages the resource availability for the assigned staff, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
Support the assessment of overall 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 all staff follows required training and completes the required documentation.
Provides regular compliance updates to management accordingly.
Participates in audits of central monitoring / clinical monitoring related to RBM / IQRM strategy and implementation and prepares others for participation in audits.
Represents the business at industry conference and through writing white papers and other thought-leadership activities.
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
Master's degree or health data sciences degree preferred.
Expert in Good Clinical Practice / ICH E6 (R2) Guidelines and / or other applicable regulatory requirements.
Expert in Risk-Based Monitoring Strategies processes and tools preferred.
Expert in Integrated Quality Risk Management (IQRM) theories.
Knowledge of and relationships with industry thought-leaders in RBM and IQRM.
Must demonstrate good computer skills and be able to embrace new technologies.
Mastery of MS Excel (sorting, filtering, calculating, pivoting).
Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers).
Knowledge of statistical analysis techniques, visualizations and tools (Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, Box and Whiskers).
Knowledge of Lean Six Sigma, RACT tools.
Strong analytical skills and well-developed understanding of statistical concepts.
Well-developed therapeutic expertise.
Excellent verbal and written communication skills.
Strong negotiation skills, organizational skills and problem-solving skills.
Demonstrated strong leadership, tactical and strategic thinking skills.
Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas.
Ability to understand, explain and communicate project concepts and put into detailed plans.
Ability to teach, train and mentor employees of all levels to achieve project, departmental, personal and organizational goals.
Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.