Senior Study Data Manager

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Within the Clinical Trial Team (CTT), the Senior Study data manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. He/She is accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. He/She ensures activities are completed according to agreed standards and timelines. He/She provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial.

Main responsibilities include:

• Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations) and for the delivery of accurate and reliable clinical study data.
• Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates.
• Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution.
• Defining and implementing data cleaning & validation strategy integrating risk-based approaches.
• Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study.
• Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers.
• Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare.

• Experience: Experience on clinical data management of which # years must have been in a project management role.
• Soft Skills: Project management skills and experience. Anticipate delivery risks.
• Learn and adapt quickly when facing new problems.
• Good interpersonal, communication, and presentation skills.
• Technical skills:Experience with CDM and related regulations (incl. ICH E6 and E8).
• Risk-based mindset focusing on Quality by Design (QbD) and on what really matters.
• Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus
• Languages:Strong English skills (verbal and written), ability to exchange fluently in a global environment.