Manager, Senior Project Manager, Clinical Database Management

ROLE SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management organization, the Manager, Senior Project Manager, Clinical Database Management 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 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 Senior 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 Senior Project Manager, Clinical Database Management will be accountable to assure process, technologies, and standards are leveraged in a consistent way across assigned projects. The Senior Project Manager works regularly with the Process and Training team to help define appropriate SOPs and ensure SOPs are relevant to DBM activities. May mentor junior staff members.

• 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.
• Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within CDS
• Leads cross-functional initiatives as needed; represents CDS/Database Management on cross-divisional initiatives
• Solves complex problems, applies previous experience outside of own area
• Demonstrates comprehensive industry knowledge; acts as SME
• May help to define and/or influence applicable SOPs and work practices
• Solves complex problems, applies previous experience outside of own area
• Oversees operational activities/projects of professional Work Teams to support short / long-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 DMM deliverables
• Ensure Quality of DBM Deliverables are on par with Organizational and Department level objectives.
• 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

• 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 Advanced features of MS Project or other enterprise project management tools

• 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.)
• PMP Certification