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 Group Lead is responsible for the provision of operational leadership and expertise in data monitoring and management with an emphasis on clinical databases supporting assigned segments of 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 Group Lead works closely with the Global Head of Clinical Database Management, Database Management Program Leads 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. The Clinical Database Management Group Lead will be accountable to assure technologies and standards are leveraged in a consistent way across a program. 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 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 the 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
- Identifies existing process/product improvements
- Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
- Takes appropriate risks to achieve desired results
- Recognizes development needs and identifies/creates development opportunities within own team
- Develops a talent base and anticipates development needs within the area of responsibility
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or equivalent
- Minimum of 7 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
- Minimum of 4 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.)
- Understanding 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%.