Director, Group Lead, Data Surveillance, Clinical Data Sciences Job at Pfizer (Chennai)

Job Description

As part of the Clinical Data Sciences group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Director, Group Lead, Data Surveillance, is responsible for delivery of all technical and operational aspects of RBM, including timely and high-quality risk-based monitoring analytics supporting the Pfizer portfolio. The Director, Group Lead, Data Surveillance will manage the Central Monitoring groups, providing oversight of central monitoring deliverables and managerial oversight of Central Monitors. The Central Monitors will support an approach to clinical trial monitoring which utilizes data and site level information to determine needs for performing on-site, remote and centralized activities and focuses resources on risks that have the most potential to impact patients’ safety and data quality. Overall, responsible for defining, delivering and executing the enterprise level RBM implementation plan including strategy and process definition, technology implementation, training, enterprise change management, and communication plan

Job Responsibility

Define and drive global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to deliver high quality clinical data
Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a project
Develop charters, resource utilization and project plans to achieve CDS specific goals
Develop people, including recruitment, retention, and career development and performance management
Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers
Provides administrative and central monitoring technical and process oversight of teams
Implements organizational design and develop succession planning for RBM in collaboration with other functional leaders
Oversee all technical aspects required to set up and test study level Risk-based Monitoring system
Anticipates, oversees and influences change to position efficient, high-quality implementation of required data flows to incorporate internal and external data sources into Pfizer informatics environment ensuring operational delivery and traceability from source. Ensures appropriate process and documentation are in place to support inspection readiness
Act as the key scientific and technical central monitoring expert
drive central monitoring strategy within Pfizer’s risk-based model, defining central monitoring standards for the asset, Therapeutic Areas (TA), or global organization
Serve as Subject Matter Expert (SME) for and oversee the central monitoring activity for one or more asset. Train and mentor colleagues and study teams on central monitoring techniques and strategy

Requirements

Bachelor’s Degree. Degree in Life Sciences, Informatics, Computer Science, Statistics, or related business degree with equivalent experience preferred
Demonstrated relevant experience in a pharmaceutical, biotech, Contract Research Organization (CRO), or Regulatory Agency with an emphasis on building data collection and assimilation solutions
Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas
Demonstrated successful experience in all relevant clinical trial activities in a Bio Pharmaceutical or CRO setting
Working knowledge of all phases of clinical trials and multiple indications and/or therapeutic areas. Ability to assess and determine study requirement from protocol review
Strong Project and Risk Management
Understanding of regulatory requirements and relevant data standards
Strong communication, decision-making, influencing, negotiation, and project management skills
Technical skill and experience using relational databases and data visualization tools, e.g. Spotfire, JReview

Nice to have

Master’s degree
Strong people management experience. Proven leadership in a global, matrix environment
Broad exposure to programming in a clinical trial environment, e.g. Python, R, SAS, SQL, EDC systems
Preferred 15 or more years’ relevant experience including team management responsibilities
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
CDISC (Clinical Data Interchange Standards Consortium) knowledge and experience
Proficient experience using commercial RBQM systems (e.g. CluePoints)
Experience with one or more programming languages (e.g. SAS, Python, R) and data visualization tools (e.g. Spotfire, jReview, Tableau)
Knowledge of risk-based monitoring principles and associated analytics/metrics
Strong verbal and written communication skills
independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment
Bachelor’s degree required. Degree in scientific, technical or analytic field preferred. Master’s degree preferred

Pfizer - All Job Offers

Select Country

Director, Group Lead, Data Surveillance, Clinical Data Sciences

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?

Director, Group Lead, Data Surveillance, Clinical Data Sciences

Educator and Infection Preventionist

Senior B2B PR & Events Manager - DACH (all genders)

Principal Product Designer - Strategic Discovery

Senior Data Analyst

Senior Operational Auditor

Fullstack Software Engineer - Article Management ZEOS

Ai Engineer

Senior Associate - Model Validation and AI Governance

Our AI answers in your language