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Associate Director, Asset Lead, Clinical Data Sciences

Pfizer
12+ years
₹60,00,000 – ₹1,20,00,000 per annum
Chennai, India
15 June 24, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

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