Senior Study Data Manager
Location: Hyderabad, India
Job Type: Permanent
Posted on: May 19, 2025
Application Deadline: May 30, 2025
Job Summary:
Sanofi’s Hyderabad Hub is inviting applications for the position of Senior Study Data Manager within the Clinical Trial Team (CTT). This role is crucial in leading and managing the end-to-end Clinical Data Management (CDM) activities, ensuring high-quality, accurate, and reliable clinical study data in accordance with GCP and global regulatory standards.
Key Responsibilities:
Ensure the quality and timely delivery of CDM deliverables, including CRFs, data plans, validation specs, and review reports.
Act as a primary CDM liaison with internal stakeholders (e.g., Global Study Manager, Statistician, Pharmacovigilance, etc.).
Identify and resolve CDM-related issues during study lifecycle phases.
Define and implement risk-based data cleaning and validation strategies.
Participate in protocol review, data deviation tracking, SAE reconciliation, and data/medical review.
Lead and mentor internal/external CDM delivery teams, including new Study Data Managers.
Manage external data sources (Central Labs, eCOA, IRT, etc.) and ensure effective data reconciliation.
Requirements:
Experience: Strong background in clinical data management with significant experience in a project management capacity.
Soft Skills:
Proven project management capabilities.
Strong communication, interpersonal, and presentation skills.
Proactive, adaptive problem-solving mindset.
Technical Skills:
Expertise in CDM standards, ICH E6/E8 guidelines.
Risk-based, Quality by Design (QbD) approach.
Familiarity with modern clinical trial concepts (DCTs, adaptive protocols, AI automation, eSource, etc.) is advantageous.
Languages: Excellent verbal and written English; capable of operating effectively in a global team.
Why Join Sanofi?
Be part of a team transforming global healthcare through science and innovation.
Endless career growth possibilities through international mobility and internal progression.
Comprehensive rewards and benefits: health and wellness programs, gender-neutral parental leave, and more.
Contribute to groundbreaking changes in Clinical Data Management practices.
Work in a diverse and inclusive environment committed to equity and innovation.
Estimated Salary: ₹25 – ₹35 LPA (based on industry benchmarks for Hyderabad and seniority level)
Gujarat :
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