ROLE SUMMARY 

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Manager, Project Manager, Clinical Database Management is responsible for the provision of project management leadership and expertise in Clinical Data Sciences with an emphasis on clinical databases and related technologies supporting assigned segments of the Pfizer portfolio. Accountabilities include project management and leadership of the design, development, and maintenance of clinical databases and other technical deliverables within Clinical Data Sciences.  Oversees the development cycle/change control of database build to ensure the integrity of clinical data and the application of Pfizer standards supporting consistency in asset/submission data. Serves as a Subject Matter Expert for database build in the assigned Therapy Area.  The Project Manager, Clinical Database Management works closely with the Clinical Data Scientist to ensure consistent, timely and high quality application of process and delivery of CDS responsibilities. The Project Manager, Clinical Database Management will be accountable to assure process, technologies, and standards are leveraged in a consistent way across assigned projects.  May mentor junior staff members 

ROLE RESPONSIBILITIES  

Works closely with department roles, assigned mentor, and cross-functional study team members to manage the development cycle of data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans. 

Solves moderately complex problems related to database build and implementation 

May aid with solving problems outside of own department 

Oversees operational activities/projects of professional Work Teams to support short-term Department goals. 

Leads internal initiatives, working with other roles within CDS to improve processes.  Represents Database Management on CDS initiatives. 

Complies with applicable SOPs and work practices 

Serve as a project management resource to the study teams for developing and implementing database development project plans. 

Ensure proper planning of study activities in DBM and proactively alert risk and plan mitigation.  

Independently, perform Impact analysis for proposed solutions to existing tools and processes and convey the same to technical and non-technical stakeholders. 

Act as an Expert in the area, applying best practices according to documented processes 

Participate in Pfizer Standards meetings as appropriate  

Ensure compliance always 

Ensure seamless functioning and collaboration of CDS activities between the DBM and Clinical Data Scientist functions.  

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 CDS deliverables 

Assess impacts of Change Control and develop mitigation plans for emerging risks and issues. 

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 result 

BASIC QUALIFICATIONS  

Bachelor's degree in Life Sciences, Computer Science, or equivalent 

Minimum of 10 years of relevant project management experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions 

Strong project management, communication (written and oral), decision-making, influencing, and negotiation skills 

Familiarity with Electronic Data Capture systems, Clinical Data Management Systems/relational databases (e.g. Oracle InForm and Data Management Workbench, MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire, J-Review) 

Experience with MSProject or other enterprise project management tools 

PREFERRED QUALIFICATIONS 

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 

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 

PHYSICAL/MENTAL REQUIREMENTS 

Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.  

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.