This is an on-site based role in San Francisco.
The Data Monitoring and Management Group Lead serves as the primary Data Monitoring and Management (DMM) point of contact at the asset level. The primary purpose is to ensure provision of internal and external strategic and operational leadership and expertise in data monitoring and management with an emphasis on effective partnering. Accountabilities include the design, development, and maintenance of key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, overseeing the application of standards, data review and query management, as well as ensuring quality study data set release and consistency in asset/submission data. Excellence in the delivery of data management deliverables is a result of effective and efficient partnering with both external partners/vendors and internal partner (e.g. DevOps China). The DMM Group Lead works closely with the DMM Head and Therapeutic Area Leads to ensure the DMM team functions as a harmonized unit with consistent, timely and high quality application of process and delivery of DMM responsibilities. Additional responsibilities will include managerial oversight and as needed technical support of Clinical Data Scientists (CDS), resource management and workload prioritization.
• Acts as the key scientific and technical data management expert at the asset level; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting
• Builds and oversees a high performing team of Clinical Data Scientists to deliver data monitoring and management expertise to Research/Business Units and other Global Product Development lines in a high quality and timely manner
• Serves as a functional driver of Quality Gates and manages Significant Quality Events (SQEs)
• Anticipates, oversees and influences change to position efficient, high-quality operational delivery
• Develops creative solutions to complex problems within and beyond scope of expertise (e.g. TA, discipline, department)
• Assumes accountability and as needed responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, and third party study data due diligence
• Manages risk appropriately to enable innovative solutions
• Establishes strong partnerships with BU/RU, department leadership and other funtions to advance asset or indication goals
• Ensure work carried out by DM providers/vendors is in accordance with applicable SOP's and working practices.
• Ensures DM work is inspection ready and acts as a key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups within Pfizer.
• Helps develop a strong talent base within group of Clinical Data Scientists, preparing for long- term development needs, via mentoring or matrix management
Qualifications
• Bachelor's degree required. Degree in scientific field preferred. Master's degree preferred.
• Knowledge of vendor processes and best practices in outsourcing. Must be capable of building strong relationships with Partners and other vendors.
• At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.
• Supervisory experience is preferred
• Oncology and Vaccines related experience is highly desirable.
• Data Management and clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations required for the reporting of clinical trials and global regulatory submissions.
• Thorough understanding of regulatory requirements and relevant data standards. CDISC knowledge and experience are preferable.
• Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills
• Sound knowledge and experience working across international boundaries and cultures.
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