Senior Associate, Senior Central Testing Analyst

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ROLE SUMMARY

As part of the Clinical Data Sciences group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Senior Central Testing Analyst is responsible for leading

the Database Testing and validation activity at a study or asset level and 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 Senior 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

Provides technical skills and knowledge to assigned work to achieve and 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.

Participate in initial DM meetings with Clinical Data Scientist (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.

Based on Study Data Specification (SDS) the Screen UAT has to be executed and compare the Schedule of Assessment from Protocol with Database and Provide Suggestions.

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

May perform peer review on programming of edit checks

May perform check on metadata listing

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 Postproduction Changes in Database during conduct and provide clinical / technical suggestion.

Communicates effectively to study team about suggestion and changes to database.

Track the lessons learned and share the knowledge across the team.

Complete all the documentation related to study and share it with study team.

Perform testing of reports and document the same.

Maintain a high customer satisfaction level and work with global study teams to meet objectives / timelines.

Able to resolve conflicts, influence and communicate with key stakeholders and customers.

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).

QUALIFICATIONS

Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP

Demonstrated knowledge of data management processes and principles in area of responsibility.

Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review

Demonstrates strong verbal and written communication skills including ability to communicate remotely

Minimum 7 years of relevant experience required

Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

Proficient experience using commercial clinical data management systems and / or EDC products (e.g., Inform preferred)

Experience using data visualization tools (e.g. Spotfire, J-Review) preferred

Familiarity with MedDRA / WHO-Drug

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Bachelor's degree minimum requirement.

Experience of project management skill in terms of resource management and timeline and quality control preferred.

Experience performing testing of database and / or leading a team of testers performing the UAT activities.

Work Location Assignment : Hybrid

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

Medical