Head, Center for Data Standards & Quality (CDSQ)
- As a senior member of the GBDM Leadership Team the Head of Center for Data Standards & Quality (CDSQ) is responsible for leading and driving data standards, quality improvement and regulatory compliance to support GBDM in delivering the highest possible quality data outputs. He/she will serve as the focal point for all data standard, quality, and vendor issues for GBDM programs. Provides leadership and coordination for the development and implementation of a cohesive, GBDM-wide approach to measuring and promoting standards and quality and leads GBDM’s prioritysetting process for quality improvement. Coordinates quality-related activities with vendors.
- Provides leadership and coordination for the development and implementation of a cohesive data driven approach to measuring and promoting quality.
- Leads priority-setting process and oversight for clinical/data standards, quality, and compliance improvement.
- Represents GBDM within the GPD quality community of practice and governances
- Owns quality-related activities with outside organizations including preferred functional service providers
- Serves as GBDM’s lead, and point-of-contact for management, oversight, budget, and performance issues relating to the data standards, quality, and compliance.
- Serves as a core member of protocol and program governance forums.
- Accountability for establishing Quality strategy in GBDM, defining and driving a common quality level and expectation across all GBDM functions and data deliverables
- Drive strategy in the space of Standards across GPD and Quality across GBDM, and have direct oversight in the forums where designs are deliberated
- Accountability to establish Quality metrics for GBDM
- Accountability to establish QTL’s for GBDM
- Align GBDM in how we apply and execute “in-process” QC and what metrics are to be collected and reported
- Oversight for the end to end standards deliverables
- Co-Chair (with Clinical Rep) of Standards Governance
- Serve as Key Opinion Leader and Subject Matter Expert within the clinical data standards and regulatory arena both internally and externally
- Drive conformity with appropriate bodies and continuous improvement
- Monitoring and reporting Vendor adherence to process
- Due diligence coordination for GBDM for Business Development and Vendors
- Manage TA standards boards through direct reports
- Project manage E2E standards deliverables through direct reports
- Coordinate functional level Standards Deliverables via TA aligned direct reports
- Work with other quality representatives to ensure cross functional, E2E quality deliverables. Provide quality knowledge related to GBDM activities to teams and functions.
- This individual, with a team of direct reports, drives consistency and compliance with regulatory expectations and company standards through quality planning, monitoring, quality control and remediation
- Drive GBDM quality; identifying key areas of focus, including areas of risk, large scale process changes and priority assets. Facilitate quality risk management planning activities to ensure consistency and rigor in preventing risk realization
- Drive consistent development of risk plans across the portfolio to identify factors that are critical to quality and pre-specify appropriate quality metrics; identify high-priority risks to quality and prospectively implement appropriate mitigation plans.
- Continuously review quality data, interpreting results, escalating issues, and supporting definition of remediation activities, as necessary
QUALIFICATIONS / SKILLS:
- Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.
- At least 14 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency with at least 7 years being the development and implementation of clinical trial processes with an emphasis on data management.
- Process and training development experience desired across Biostatistics, Data Management, Statistical Programming 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
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Medical