Job Title
Associate Director – Asset Lead, Clinical Data Sciences
Company
Pfizer
Location
India – Chennai
Function
Global Biometrics and Data Management (GBDM) – Data Monitoring & Management
Job Overview
The Associate Director – Asset Lead in Clinical Data Sciences is responsible for leading end-to-end clinical data management strategy and execution across one or more clinical assets. The role ensures high-quality, timely, and compliant clinical data delivery supporting clinical development, regulatory submissions, and precision medicine initiatives. It includes leadership of data management teams, oversight of standards, and accountability for data integrity across studies and programs.
Key Responsibilities
1. Asset-Level Data Strategy & Leadership
Lead data management strategy across one or multiple clinical assets
Define and implement asset-level information strategies for data reuse and quality
Oversee delivery of all Data Monitoring & Management (DMM) activities
Manage large or multiple clinical study portfolios
2. Clinical Data Science & Trial Leadership
Serve as Clinical Data Scientist and Trial Lead for selected studies
Oversee Data Management Plans (DMPs) and data acquisition standards
Define quality risk indicators and data monitoring strategies
Ensure alignment of data strategy with protocol requirements
3. Clinical Data Systems & Standards
Act as SME for design and implementation of CRF and non-CRF data collection tools
Oversee EDC system setup (e.g., Medidata RAVE, Oracle Inform/RDC)
Ensure application of data standards across therapeutic areas
Drive consistency in study data design and implementation
4. Data Integrity & Risk-Based Monitoring
Implement centralized data monitoring and analytics strategies
Ensure ongoing data quality oversight across multiple studies
Apply risk-based monitoring principles and metrics
Ensure data integrity across collection, cleaning, and reporting stages
5. Regulatory & Compliance Oversight
Ensure compliance with SOPs, FDA, ICH, GCP, and GCDMP guidelines
Act as key data management contact during audits and regulatory inspections
Ensure readiness for inspections and quality assessments
Support data-related due diligence for licensing and collaborations
6. Vendor & Stakeholder Management
Oversee CROs and external vendors for data management delivery
Ensure vendor performance meets timelines and quality expectations
Collaborate with cross-functional clinical, statistical, and safety teams
7. Tools, Systems & Technical Expertise
Work with clinical databases (Oracle, Medidata RAVE, etc.)
Use relational databases (SQL Server, Oracle, MS Access)
Leverage data visualization tools (Spotfire, jReview)
Ensure coding standards (MedDRA, WHO-Drug) are followed
8. Leadership & Team Management
Lead and mentor data management teams (direct/indirect reports)
Drive cross-functional collaboration in matrix environments
Build capability and ensure high-performance delivery culture
Required Qualifications
Bachelor’s degree (Life Sciences/Scientific field preferred)
Master’s degree preferred
12+ years clinical data management experience
5+ years in team leadership within pharma or CRO industry
Strong knowledge of clinical trial phases and protocol interpretation
Experience in vendor oversight and global study execution
Strong regulatory knowledge (FDA, ICH, GCP, GCDMP)
Hands-on experience with EDC systems and clinical databases
Knowledge of MedDRA and WHO-Drug coding
Experience in risk-based monitoring and analytics tools
Strong communication and stakeholder management skills
Core Competencies
Strategic leadership and decision-making
Strong analytical and risk management capability
Cross-functional collaboration in matrix environments
High attention to data quality and integrity
Vendor and project management expertise
Regulatory and compliance mindset
Ability to manage multiple global assets
Uttar Pradesh :
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