Associate Director, Asset Lead, Clinical Data Sciences
- India - Chennai
ROLE SUMMARY
As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Asset Lead is responsible for timely and high quality data management deliverables supporting the company portfolio. Responsibilities include delivery of asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the company portfolio and further precision medicine. The Asset Lead is expected to manage large or several smaller assets and may directly or indirectly design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Asset Lead may have direct reports.
ROLE RESPONSIBILITIES
•As needed, serve as Clinical Data Scientist & Trial Lead for one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
•Act as the key scientific and technical data management expert; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as RBM standards, tools, data provisioning, and reporting
•Ensure work carried out by or on behalf of DMM is in accordance with applicable SOPs and working practices.
•Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.
•Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics.
•Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals, and clinical research collaborations as required.
• Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups.
QUALIFICATIONS
Minimum 12 years Clinical Data Management experience required including 5+ years team leadership in pharmaceutical industry or CRO setting.
Working knowledge of all phases of Clinical trials and ability to assess and determine study requirement from protocol review
Strong Project and Risk Management
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. Medidata RAVE, Oracle RDC / Inform, etc)
Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)
Familiarity with MedDRA/WHO-Drug coding
Knowledge of risk-based monitoring principles and associated analytics/metrics
Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables
Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment
Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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MedicalBreakthroughs that change patients’ lives
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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.
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- 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.
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