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 teamImplement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverablesDevelop charters, resource utilization and project plans to achieve CDS specific goalsImplements organizational design and develop succession planning for RBM in collaboration with other functional leadersDevelop people, including recruitment, retention, and career development and performance management

　　Specific:

　　Ensure compliance to Pfizer RBM processParticipate in central monitoring specific process improvement initiativesManage the CM team to CDS metrics goals and resolve cross-functional barriers to achieving central monitoring milestonesEnsure appropriate resources are identified to support the RBM studiesEnsure that all central monitoring activities are conducted in compliance with relevant regulatory requirementsMonitor and report on implementation of functional area initiativesImplement central monitoring strategies to ensure clear and transparent processes in strong collaboration with related partnersImplement 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 requiredExtensive clinical development and business experience in order to have a thorough understanding of the processes including risk management and central monitoringMinimum 7 years working experience in the clinical development fieldsWorking knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study designHistory of achievement in a customer service role with demonstration of meeting customer needs and concerns.History of achievement in building strong customer relationshipsLeadership, 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 organizationStrong background in provision of high levels of Customer Service evidenced by positive feedback from customersDemonstrated 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 rolesDemonstrated platform skills; experience presenting to large scientific audiences and non-science populationsUnderstand and has demonstrated ability to manage large and complex budget; history of staying on or under budget.Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

　　PREFERRED QUALIFICATIONS:

　　Master's degreeTechnical proficiency in using data visualization toolsProficient experience using commercial clinical data management systems and/or EDC productsThorough understanding of regulatory requirements and relevant data standardsKnowledge of clinical trial database and its applicationsKnowledge of basic statistical principles and statistical methodologyPrevious 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.

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　　Purpose

　　Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

　　Digital Transformation Strategy

　　One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

　　Flexibility

　　We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

　　Equal Employment Opportunity

　　We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

　　Medical

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