Clinical Data Services Specialist – Life Sciences R&D
Job ID: AIOC-S01623254
Employment Type: Full Time
Role Type: Clinical Data Services Team Lead / Consultant
Location: Bengaluru, India
Experience Required: 7–11 Years
Job Overview
The Clinical Data Services Specialist will be a key contributor within the Life Sciences R&D vertical, supporting global clinical research programs through high-quality clinical data management and governance. This role focuses on ensuring accurate, compliant, and timely clinical trial data to enable effective safety, efficacy, and regulatory decision-making for biopharmaceutical clients.
Key Responsibilities
Manage and oversee clinical data services activities across multiple clinical trials, ensuring data integrity, quality, and regulatory compliance.
Support end-to-end clinical data management processes, including data collection, validation, reconciliation, storage, and analysis.
Deliver high-quality clinical data management outputs aligned with customer expectations, regulatory guidelines, and industry best practices.
Collaborate with cross-functional clinical teams to support study conduct, management, and analysis throughout the clinical research lifecycle.
Ensure adherence to global regulatory standards and data governance requirements for successful trial outcomes.
Utilize industry-standard clinical data management systems to manage trial data efficiently and accurately.
Establish and maintain strong client relationships while supporting consulting-led delivery models.
Role Focus: Clinical Data Management
Support the conduct, management, and analysis of clinical studies across the full spectrum of clinical research, in line with NIH-defined research frameworks.
Ensure optimal data quality, cost efficiency, and availability throughout the clinical trial lifecycle.
Apply strong attention to detail to identify, resolve, and prevent data discrepancies.
Required Skills & Competencies
Core Skills
Clinical Data Services
Clinical Data Management (CDM)
Life Sciences R&D
Technical & Domain Expertise
Hands-on experience with clinical data management platforms; Medidata RAVE EDC exposure is strongly preferred.
Strong understanding of clinical trial processes, CDM principles, and global regulatory guidelines (ICH-GCP, FDA, EMA).
Professional Skills
Strong problem-solving and analytical abilities.
High attention to detail and accuracy.
Ability to perform under pressure in fast-paced project environments.
Excellent organizational, communication, and stakeholder management skills.
Adaptable and flexible approach to changing project requirements.
Education & Experience Requirements
Master of Science (MSc) in Life Sciences, Clinical Research, or a related discipline.
Minimum 7 to 11 years of relevant experience in clinical data management or clinical data services.
Prior experience working in a Clinical Data Manager or equivalent role is highly desirable.
Why This Role
This position offers an opportunity to work with leading global biopharmaceutical organizations, contributing to high-impact clinical research initiatives. You will be part of a consulting-led life sciences team that supports innovation, regulatory compliance, and improved patient outcomes through data-driven clinical development.
Gujarat :
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