Graduates Vacancy at Pfizer

Overview:

Pfizer is hiring an experienced Senior Associate, Central Testing Analyst at their Chennai location. As part of the Clinical Data Sciences (CDS) 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 CDS Clinical Data Sciences and Clinical Database Management groups for timely delivery of CDS responsibilities. The role also has additional responsibilities supporting development, system upgrades, and technical processes and accountable for timely and high quality deliverables supporting the Pfizer portfolio.

The complete details of this job are as follows:

Roles and 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.
• 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 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.
• Review the Edit Check Specification, write UAT test Scripts.
• 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.

Qualification:

• Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.
• Bachelor’s degree minimum 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 UATPrevious 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 (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 (g. Spotfire,  J-Review)
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Disclaimer: The Recruitment Information provided above is for informational purposes only. The above Recruitment Information has been taken from the official site of the Organisation. We do not provide any Recruitment guarantee. Recruitment is to be done as per the official recruitment process of the company or organization posted the recruitment Vacancy. We don’t charge any fee for providing this Job Information. Neither the Author nor Studycafe and its Affiliates accepts any liabilities for any loss or damage of any kind arising out of any information in this article nor for any actions taken in reliance thereon.