ROLE SUMMARY

　　As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Associate Central Testing Analyst is responsible for performing testing of database (UAT) and ensuring that the CRFs are designed in accordance to protocol and the end users are able to enter the data as per the standards and expectation. In addition to the screen testing the Associate Central Testing Analyst will also be responsible to perform the testing of data specification to ensure that the checks are rightly programmed, appropriate and adequate as per the protocol requirement.

　　ROLE RESPONSIBILITIES

　　Perform activities, including but not limited to: the testing of CRF design, Database building, Acquisition & Processing of electronic data, such as external eData, Lab Data and PK/PD Data; Data extraction and listing for quality review, Data Visualization; Data and Documentation Processing, CRF and Database edit checks/validation and outputs.Accountable for high quality and on time delivery for assigned deliverables.Ensure the consistent use and application of applicable data standard and ensures data quality and consistency across programs and repositories.Solid knowledge/understanding of the SDLC and testing methodology; document management.Participate in initial DM meetings with CDS to understand the expectation and scope of the study.Ensure work carried out in accordance with applicable SOPs and working practices.Understand the Protocol and provide input to Study Team on Database Design and Edit Check Specification as appropriate.Review the Edit Check Specification, write UAT test Scripts.May perform the peer review for programming checks.May perform the QC on metadata listings.Participate in UAT feedback meetings.Streamline/Standardize the Scripts for Standard Forms/Edit Checks.Validation of Manual queries/Listings (Standards/Therapeutic Specific).Able to understand the Post Production Changes in Database during conduct and provide clinical/technical suggestion.Track the lessons learned and share the knowledge across the team.Complete all the documentation related to study and share it with study Team.

　　QUALIFICATIONS

　　Awareness of clinical development and pharmaceuticals as a regulated industryAwareness of healthcare regulatory authorities (e.g. FDA, Health Canada)Ability to learn clinical data management processes and principles in area of responsibility.Demonstrates required verbal and written communication skills including ability to communicate remotelyCapable to learn technical data systemsCapable to learn how to use data visualization tools (e.g. Spotfire, J-Review)Previous experience within a database management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, data transfer activities.Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)Bachelor's degree minimum requirement. Health Sciences experience or Technology degree preferred.At least 2 years of relevant experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.Must have experience writing test cases and preforming UAT

　　PHYSICAL/MENTAL REQUIREMENTS

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

　　NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

　　Ability to travel ~5%.

　　Work Location Assignment: Flexible

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

　　Medical

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