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.
Setting up study Configuration and building data models .
Setting up data transformations, coding complex custom programs .
Deep understanding of Validation Checks, custom programs, listings, and filters, and set up reference data.
Hands on experience in Oracle's Data Management Workbench (DMW) required.
Good understanding of the Integration of DMW with any edc tool (preferably InForm)
Good understanding of LSH architecture. (logical domains application areas in terms of refining / streamlining the container models in LSH application .
Support the configuration of hierarchies in LSH application to facilitate data browse and search features.)
Cross Functional expertise working with System Designers, Statistical Programmers, and Data Managers to build robust systems.
Technical and clinical business sense to support and maintain clinical database from a data perspective.
Strong PL/SQL skills .
Ability to travel approximately 5 to 10%.
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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.
Last date to apply by: 3/8/2019
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.