As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management organization, the Clinical Database Management Program Lead is responsible for the provision of operational leadership and expertise in data monitoring and management with an emphasis on clinical databases supporting the Pfizer portfolio. Accountabilities to include design, development, and maintenance of clinical databases, ensuring the integrity of clinical data, application of standards supporting consistency in asset/submission data. The Clinical Database Management Program Lead works closely with the Global Head of Clinical Database Management and DMM Therapeutic Area (TA) 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. This role has additional line management responsibilities supporting development, system/technical processes, resources and colleague development.
- Works closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data capture and management tool and methods required per standard and study specific data review plans.
- Complies with applicable SOPs and work practices
- Serves on the data standards board as needed, and leads as needed implementation and where needed development of data management reporting standards
- Serve as a technical resource to program level and study teams for data capture and assimilation deliverables
- Ensure operational excellence in collaboration with partners and colleagues for application of standards within data capture methods in support of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables
- Directly supports knowledge development of data capture tools and methods that support the accuracy and integrity of study data
- Champions innovation
- Develops and leverages resources to implement innovative ideas/processes/ products across the Pfizer enterprise
- Takes appropriate risks to achieve desired results; guides direct reports on acceptable levels of risk-taking
- Assesses the talent needs and identifies talent within the organization to ensure bench strength for critical roles
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or equivalent
- Minimum of 10 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
- Minimum of 7 years in a management role with experience in second line management and functional leadership
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable
- Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills
- Technical skills and experience using relational databases (e.g. Oracle InForm, MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire, J-Review)
- Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
- Ability to travel approximately 5 to 10%.