As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Business Process and Training Lead is accountable for ensuring that processes and training are sufficiently robust to ensure inspection readiness is a routine part of the daily work. The Business Process and Training Lead ensures processes are kept current, training is focused on optimized delivery of those processes and appropriate levels of testing are in place ensuring that DMM is inspection and audit preparedness. This role ensures a balance of e-Learning and live learning opportunities. The Business and Training Lead is also responsible for ensuring continuous improvement that results in innovative and industry leading processes at Pfizer.ROLE RESPONSIBILITIES
- Reporting to the Global Head Central Services Data Monitoring and Management (DMM), the Business Process and Training Lead will leverage their technical knowledge base and leadership abilities to deliver the responsibilities and services that include DMM Inspection and Audit Readiness, business process creation and life cycle management and department training
- Acts as business process and training for Data Management SOPs as needed and as a point of contact for creation, maintenance/updates, and interactions between internal and external partners, as well as when needed acting as a decision maker for selected DM processes and related systems.
- Monitors and provides process oversight to ensure on an ongoing basis the quality of data deliverables produced by functional lines and DM vendors is consistent and meets the highest integrity standards.
- Works with Business Process Owners (within and outside DMM) to drives data quality improvement, identifying opportunities to improve processes and controls in support of data integrity and submissions quality, and working to ensure quality and continuous improvement practices are fully integrated with the appropriate functional lines.
- Collaborating with DMM colleagues and colleagues outside of DMM to ensure the development and execution of all CAPA commitments from inspection and audit findings.
- Maintains an active awareness of the technological and regulatory landscape both within and outside of Pfizer that impacts on DMM processes
- Participates with functional leadership to develop robust performance metrics that are intended to both evaluate data health, data compliance and to ensure correct execution of DMM tasks to standards of quality and inspection readiness
- Drives the development of forums that facilitate the sharing of best practices and the development of knowledge
- Within functional leadership, ensures DMM roles have appropriate skill development content in place
- Establishes strong partnerships with BU/RU, department leadership and other functions to advance asset or indication goals
- Works with DMM leadership to ensure work carried out by or on behalf of DMM is in accordance with applicable SOP's and working practices.
- Helps develop a strong talent base and preparing for long-term development needs, via mentoring or matrix management
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Bachelor's degree required. Degree in scientific field preferred. Master's degree preferred.
- At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency with at least 5 years being the development and implementation of clinical trial processes with an emphasis on data management.
- Supervisory experience (>8 years) required
- Process and training development experience desired
- 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.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Ability to travel approximately 10 to 20%.
#LI-REMOTEPfizer 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.Sunshine Act
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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.