Senior Associate, Senior Central Testing Analyst, Central Services
- India - Chennai
Use Your Power for Purpose
Our mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.
What You Will Achieve
In this role, you will:
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: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
MedicalBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)