Central Testing Analyst

Job Description

As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the 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 Central Testing Analyst will also be responsible to perform the testing of data specification and listings to ensure that the checks are rightly programmed, appropriate and adequate as per the protocol requirement. The Central Testing Analyst will also work closely with the DMM Clinical Data Sciences and Clinical Database Management groups for timely delivery of DMM responsibilities. The role also has additional responsibilities supporting development, system upgrade/technical processes and accountable for timely and high quality deliverables supporting the Pfizer portfolio.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, ECG Data, PK/PD Data, etc. Data extraction, Data Visualization; Data and Documentation Processing, CRF and Database edit checks/validation and validation of exceptional reports/listings.
• Accountable for high quality and on time delivery for assigned deliverables.
• Solid knowledge/understanding of the Software development, Lifecycle testing methodology; document management.
• Participate in initial Data Management meetings with Clinical Data Scientist or Study Data Manager to understand the expectation and scope of the study requirements.
• Ensure work carried out in accordance with applicable standard operating procedures and working practices.
• Understand the Protocol and provide input to Study Team on Database Design and Edit Check Specification as appropriate.
• Execute Screen UAT based on Study Data Specification (SDS)
• Review the Edit Check Specification, write UAT test Scripts.
• Execute the scripts and log the issues in UAT tracker and provide feedback to Study Team
• Perform UAT for DMW Validation Checks and SRDM UAT for assigned studies
• May be involved in Validating the Automation Tools for Data Management
• Perform the peer review for programming checks.
• 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.
• Organizes own work to time to meet agreed milestones and targets; develops plans for short-term work activities on own assignments (timelines, work plans, deliverables).
• Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management).
• Able to resolve conflicts, influence and communicate with key stakeholders and customers.

QUALIFICATIONS

• Bachelor s degree minimum requirement. Health Sciences experience or Technology degree preferred. At least 4 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 performing UAT
• Previous experience within a database management role, understanding key processes and principles associated with CRF design, database build (including edit checks, validation and outputs), data transfer activities, listing and reporting. Awareness of clinical development and pharmaceuticals as a regulated industry
• Awareness 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 remotely
• Capable to learn technical data systems
• Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Proficient experience using commercial clinical data management systems and/or EDC products (e.g. , InForm preferred)
• Experience of project management skill in terms of resource management and timeline and quality control preferred.

PHYSICAL/MENTAL REQUIREMENTSPrimarily an office-basedposition 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%.ORGANIZATIONAL RELATIONSHIPSReporting relationship to Central Services Lead, DMM.Supports Study and Asset teams across all the Research/Business Units (R/BU) within Pfizer.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical #LI-PFE,

Keyskills :
equal employment opportunitytest caseswriting test casesstandard operating proceduresclinical data managementstatements of work sow