Manager, Project Manager, Clinical Database Management, Clinical Data Sciences

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. Accountability includes 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

• Bachelors degree in Life Sciences Computer Science or equivalent

• Minimum of 5 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.)

Work Location Assignment:Hybrid

Please apply by sending your CV and a motivational letter in English

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