Centralized Study Specialist I | Full-Time | Bangalore, India (Hybrid)
Experience Required: 5–8 years
Job Description:
We are seeking an experienced Centralized Study Specialist I to support clinical trial operations through centralized study management, system oversight, and data coordination. This role plays a critical part in ensuring efficient study execution by managing clinical systems, supporting documentation, and coordinating with cross-functional teams to maintain compliance and data quality.
The ideal candidate will have strong experience in clinical research operations, study systems, and stakeholder coordination within a CRO or pharmaceutical environment.
Key Responsibilities:
Clinical Systems & Data Management
Manage and maintain clinical trial systems including CTMS, EDC, IWRS, and other study platforms.
Support study database setup, access management, and system configuration for new and ongoing studies.
Collaborate with Data Management and Programming teams for data-related tasks, reporting, and issue resolution.
Perform data review activities, identify discrepancies, and follow up with CRAs for timely resolution.
Study Operations & Support
Generate and analyze study-specific reports as per project requirements.
Support study teams with operational activities, including study start-up, execution, and close-out.
Ensure compliance with CTMS and study documentation standards.
Assist in preparing investigator submission packages and regulatory documentation.
Manage internal and external communications related to study activities.
eTMF & Documentation Management
Support Trial Master File (eTMF) management, including document collection, review, tracking, and filing.
Ensure all study documentation is complete, accurate, and audit-ready.
Maintain project and technical documentation in line with SOPs and regulatory requirements.
Investigator Payments & Financial Coordination
Review EDC and contract data to process investigator payments and mark payment readiness in CTMS.
Coordinate invoice generation, quality checks, and approvals with project stakeholders.
Manage payment reconciliation, including out-of-pocket and pass-through expenses.
Quality, Compliance & Process Improvement
Ensure adherence to ICH-GCP guidelines, SOPs, and regulatory requirements.
Perform quality checks on deliverables and ensure high standards of accuracy and compliance.
Track study metrics, escalate issues, and support timely resolution.
Identify opportunities for process improvements and support implementation of new tools and workflows.
Leadership & Collaboration
Act as Associate Lead/Lead for assigned projects where applicable.
Mentor and train new team members, ensuring knowledge transfer and team development.
Facilitate meetings and collaborate effectively with cross-functional teams including CRAs, project managers, and sponsors.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related healthcare field (preferred).
5–8 years of experience in clinical research, clinical operations, or study management roles.
Strong knowledge of ICH-GCP guidelines and clinical trial processes.
Experience working with clinical systems such as CTMS, EDC, IWRS, and eTMF.
Proven ability to manage multiple tasks, prioritize effectively, and meet deadlines.
Excellent communication, interpersonal, and organizational skills.
Strong attention to detail and problem-solving capabilities.
Preferred Skills:
Experience in mentoring and leading small teams or project activities.
Ability to work in flexible shifts based on business requirements.
Familiarity with study budgets, contracts, and payment processes.
Location: Bangalore, India (Hybrid Work Model)
Why Join Us:
Work on global clinical trials with a focus on operational excellence and compliance.
Collaborate with multidisciplinary teams in a fast-paced research environment.
Gain exposure to advanced clinical systems and study management processes.
Access career growth opportunities, training, and professional development.
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