Senior Manager, Central Monitor Lead, Risk Based Monitoring

Pfizer
Πλήρης απασχόληση Γεμάτη μέρα
Αθήνα

Why Patients Need You

Pfizer Global Product Development colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve.

The Senior Manager, Central Monitor (CM) Lead, Risk Based Monitoring, Clinical Data Sciences (CDS) provides oversight of central monitoring deliverables and managerial oversight of Central Monitors. The CM Lead is responsible for consistent harmonized processes and implementation of excellence for RBM deliverables and is accountable for delivery of functional area goals. It may directly or indirectly participate in study activities such as CRF Development, risk analysis, defining and programming analyses in the central monitoring platform, e.g. CluePoints, interpreting and presenting key risk indicators (KRIs) and data quality assessments (DQAs) that identify emerging study-specific risks including data trends and outliers. The CM Lead provides functional leadership and management of strategies for the team specific implementation of technology-enabled processes and participates with CDS management, internal Pfizer global formulating strategies and standards to be implemented for all RBM programs and to take responsibility for the implementation. The 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.


 


How You Will Achieve It

General



  • Provide administrative and central monitoring technical and process oversight of team

  • Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables

  • Develop 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 and equivalent experience in a scientific or business related discipline required

  • Extensive clinical development and business experience in order to have a thorough understanding of the processes including risk management and central monitoring

  • Minimum 7 years working experience in the clinical development fields

  • Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design

  • History of achievement in a customer service role with demonstration of meeting customer needs and concerns.

  • 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

  • Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers

  • 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

  • Understand and has demonstrated ability to manage large and complex budget; history of staying on or under budget.


 


PREFERRED QUALIFICATIONS:



  • Master's degree

  • Technical proficiency in using data visualization tools

  • Proficient experience using commercial clinical data management systems and/or EDC products

  • Knowledge of clinical trial database and its applications

  • Previous experience leading a substantial group responsible for risk management, data management and/or study management function, or equivalent.

  • Hands -on experience in Oracle, PL/SQL, SAS, Java, R/R-Shiny, Python, relational database design and database programming skills.


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


To apply please visit our website www.pfizercareers.com and search job Senior Manager, Central Monitor Lead, Risk Based Monitoring id 4900604.

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