ROLE SUMMARY

• The Sr. Manager, Central Monitor (CM) Lead, Data Surveillance provides oversight of central monitoring deliverables and managerial oversight of Central Monitors. The Sr. Manager, CM Lead is responsible for consistent harmonized processes and implementation of excellence for Risk-based monitoring (RBM) deliverables and is accountable for delivery of functional area goals. The Sr. Manager, CM Lead provides functional leadership and management of strategies for the team specific implementation of technology-enabled processes. The Sr. Manager CM Lead creates, maintains and assumes accountability for a culture of high customer service to facilitate communication, transparency of operations, clarity of workload balance and alignment.

ROLE RESPONSIBILITIES

General:

• Provide administrative and central monitoring technical and process oversight of team
• Assist to global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables
• Implement charters, resource utilization and project plans to achieve CDS specific goals
• Implements organizational design and develop succession planning for RBM in collaboration with other functional leaders
• Develop people, including recruitment, retention, and career development and performance management

      

Specific:

• Ensure compliance to Pfizer RBM process
• Participate in central monitoring specific process improvement initiatives
• Manage the CM team to CDS metrics goals and resolve cross-functional barriers to achieving central monitoring milestones
• Ensure appropriate resources are identified to support the RBM studies
• Ensure that all central monitoring activities are conducted in compliance with relevant regulatory requirements
• Monitor and report on implementation of functional area initiatives
• Implement central monitoring strategies to ensure clear and transparent processes in strong collaboration with related partners
• Implement strategies to ensure speed and quality of RBM system setup, data analysis, signal creation and other activities supported by Central Monitor

BASIC QUALIFICATIONS

• Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required
• 7+ years of business experience and extensive clinical development in order to have a thorough understanding of the processes including risk management and central monitoring 
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns.  History of achievement in building strong customer relationships
• Leadership, project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization
• Demonstrated knowledge and success in managing RBM system development, risk management, data management, site monitoring, etc.
• Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
• Demonstrated ability to manage complex projects and processes.  Established history of timely and quality delivery.
• Demonstrated success/results in prior scientific/administrative management roles
• Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations
• Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
• Business English required.

PREFERRED QUALIFICATIONS

• Previous experience leading a substantial group responsible for risk management, data management and/or study management function, or equivalent. 
• Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
• Knowledge of clinical trial database and its applications
• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.
• Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers
• Understand and has demonstrated ability to manage large and complex budget; history of staying on or under budget.

  
Work Location Assignment: Hybrid

Please apply by sending your CV and a motivational letter in English

Medical

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