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Senior Manager, Central Monitor Lead, Risk Based Monitoring
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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:

  • BSc degree or above
  • Extensive clinical development and business experience in order to have a thorough understanding of the processes including risk mgmnt 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.
  • History of achievement in building strong customer relationships
  • Leadership, project mgmnt, resource mgmnt (staff and financial), administrative & technical capabilities are required, as well as effective verbal and written comms skills in relating to colleagues and associates
  • Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers
  • Knowledge and success in managing RBM system development, risk mngmt, data mngmnt, site monitoring, etc.
  • Thorough understanding of the processes associated with clinical study mngmt, data mngmt, and regulatory operations.
  • Demonstrated ability to manage complex projects and processes.
  • Demonstrated success/results in prior scientific/administrative mngmt roles
  • Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations
  • 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



PREFERRED QUALIFICATIONS:

  • Master's degree
  • Technical proficiency in using data visualization tools & cllinical data mgmnt systems and/or EDC products
  • Thorough understanding of regulatory requirements and relevant data standards
  • Knowledge of clinical trial database and its applications and of basic statistical principles & methodology
  • Previous experience leading a substantial group responsible for risk mgmnt, data management and/or study mgmnt 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 id 4900604 for Senior Manager, Central Monitor Lead, Risk Based Monitoring

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