Job Posting: Senior Associate / Senior Central Testing Analyst – Pfizer, Chennai
Summary: Pfizer is seeking a highly motivated and experienced Senior Associate / Senior Central Testing Analyst to join our dynamic clinical data management team in Chennai, India. This role is pivotal in ensuring the integrity and accuracy of clinical trial data through comprehensive testing and validation activities. If you possess a strong background in UAT testing, CRF design validation, edit checks, clinical database testing, and eData processing, with a passion for contributing to impactful clinical research, we encourage you to apply. This is a full-time, hybrid position offering excellent opportunities for professional growth and development within a globally recognized pharmaceutical leader.
About Pfizer:
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines, as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.
Job Description:
We are currently seeking a Senior Associate / Senior Central Testing Analyst to join our team in Chennai. As a Senior Central Testing Analyst, you will play a crucial role in the quality assurance of our clinical data management processes. You will be responsible for leading database testing, validation activities, and CRF design reviews, ensuring that our clinical trial data meets the highest standards of accuracy and compliance.
Key Responsibilities:
- Lead database testing and validation efforts for clinical trial databases.
- Conduct thorough CRF design reviews to ensure protocol alignment.
- Execute User Acceptance Testing (UAT) for screens based on Study Data Specifications (SDS).
- Review edit check specifications and write and execute UAT scripts to validate their functionality.
- Log UAT issues meticulously, participate in feedback meetings, and proactively provide constructive suggestions for improvement.
- Validate manual queries, listings, metadata, and post-production updates to maintain data integrity.
- Ensure strict compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), relevant regulatory guidelines, and Pfizer’s quality standards.
- Collaborate effectively with Clinical Data Scientists and global study teams to ensure seamless data management processes.
- Provide technical expertise and input for database design, eData acquisition, and the handling of lab and PK/PD data.
- Maintain comprehensive documentation of testing activities and contribute to knowledge-sharing initiatives within the team.
- Utilize tools such as Inform EDC, Spotfire, J-Review, and Microsoft Office Suite to effectively perform testing and validation tasks.
Qualifications & Skills Required:
- Bachelor’s degree in Life Sciences or a related field is required.
- A minimum of 7 years of relevant experience in clinical data management, specifically in UAT testing, is essential.
- A strong understanding of clinical trials, GCP guidelines, Good Clinical Data Management Practices (GCDMP), and relevant FDA & ICH regulations is mandatory.
- Expertise in Electronic Data Capture (EDC) systems, with a preference for experience using Inform EDC.
- Knowledge of medical coding dictionaries such as MedDRA and WHO-Drug is highly desirable.
- Experience with data visualization tools, such as Spotfire or J-Review, is preferred.
- Excellent communication, interpersonal, and stakeholder management skills are crucial for effective collaboration within global teams.
- Project management experience is considered a valuable asset.
Benefits of Working at Pfizer:
- Become part of a globally recognized leader in clinical research and development.
- Enjoy the benefits of a hybrid working model, promoting improved flexibility and work-life balance.
- Thrive in a collaborative and diverse work culture, fostering innovation and professional growth.
- Access numerous opportunities for global exposure and career advancement within the organization.
- Participate in comprehensive employee well-being programs designed to support your physical, mental, and financial health.
To Apply:
If you are a highly motivated and experienced clinical data management professional seeking a challenging and rewarding opportunity, we encourage you to apply for the Senior Associate / Senior Central Testing Analyst position at Pfizer in Chennai. Please submit your application through our online career portal. We look forward to reviewing your application and learning more about your qualifications and experience.