EG-Senior Associate, Project Manager, Clinical Database Management

ROLE SUMMARY

As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management organization, the Senior Associate, Project Manager, Clinical Database Management (DBM) is responsible for the provision of project management leadership and expertise in data monitoring and management 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 Data Monitoring and Management.  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. 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 DMM 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.

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.
• Complies with applicable SOPs and work practices
• Develops and implements database development project plans, with input from a mentor.
• Ensure proper planning of study activities in DBM and proactively alert risk and plan mitigation.
• Perform Impact analysis for proposed solutions to existing tools and processes and convey the same to technical and non-technical stakeholders under the guidance of a mentor
• Participate in Pfizer Standards meetings as appropriate
• Ensure compliance always
• Ensure seamless functioning and collaboration of DMM 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 DMM 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

Qualifications:

BASIC QUALIFICATIONS

• Bachelor's degree in Life Sciences, Computer Science, or equivalent
• Minimum of 2 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.)

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

Medical