Centralized Study Specialist I
Location: Bangalore, India
Employment Type: Full-Time
Job Requisition ID: 256139
Application Deadline: January 31, 2026
Experience Required: 5–8 Years
Industry: Clinical Research / CRO / Life Sciences
Job Overview
We are hiring a Centralized Study Specialist I to support end-to-end clinical trial operations through centralized monitoring, study coordination, and data tracking activities. This role plays a critical part in ensuring trial efficiency, compliance, and high-quality execution across global clinical studies.
The ideal candidate will bring strong clinical research experience, hands-on knowledge of clinical systems, and the ability to collaborate effectively with cross-functional teams, CRAs, vendors, and investigators.
Key Responsibilities
Study Operations & Compliance
Adhere to all applicable Standard Operating Procedures (SOPs) and Work Instructions.
Execute day-to-day study activities with a focus on quality, productivity, and compliance.
Support centralized monitoring and reporting plans, including specialized monitoring requests for approved protocols.
Track, analyze, and report study metrics as defined by management within required timelines.
Proactively identify process improvement opportunities and support implementation initiatives.
Clinical Systems & Documentation
Manage and maintain clinical trial systems including CTMS, EDC, IWRS, and related platforms.
Support eTMF management, including document filing, QC, tracking, and archival activities.
Maintain accurate study databases, trackers, and project documentation.
Prepare CRA Prep Packs and coordinate with CRAs and clinical teams to resolve outstanding site issues prior to visits.
Study Coordination & Communication
Track and follow up with CRAs on outstanding action items and site-related issues.
Provide consolidated site issue snapshots to clinical teams to improve site visit efficiency.
Manage internal and external study communications.
Support training compliance for study teams.
Assist with site and vendor payments, invoice tracking, and purchase order requisitions.
Project & Vendor Support
Update study timelines and milestones in MS Project, CTMS, governance tools, and trackers; escalate risks proactively.
Assist Project Leads or Functional Leads with project plans, reviews, and execution coordination.
Support vendor management activities and documentation.
Initiate and manage RIM changes, PCC logs, and impact tracking.
Handle PII assessments, system documentation, and XRIM updates.
Implement approved Xcellerate Intelligence for Trial Efficiency (XITE) customizations and collaborate with functional leads to resolve alerts.
Leadership & Collaboration
Mentor and train junior team members as required.
Support senior-level responsibilities on projects with multiple centralized delivery associates.
Actively contribute to TMF, CTMS, and overall project health metrics.
Collaborate cross-functionally to remove barriers and ensure successful study delivery.
Education & Qualifications
Bachelor’s degree in Life Sciences preferred, or certification in an allied health profession (e.g., Nursing, Medical Technology, Laboratory Technology).
Fortrea may consider equivalent experience in lieu of formal education.
Candidates without a life sciences background but with relevant clinical research experience may also be considered.
Experience Requirements
5–8 years of relevant clinical research experience in pharmaceutical companies, CROs, or healthcare settings.
Experience with clinical trial operations, start-up, or regulatory processes.
Familiarity with investigator start-up documentation, contracts, and budget negotiation is preferred.
Prior interaction with operational project teams and investigative sites is advantageous.
Required Knowledge & Skills
Working knowledge of ICH-GCP, IRB/IEC, regulatory guidelines, and clinical trial processes.
Strong organizational, communication, and time management skills.
High attention to detail with the ability to deliver consistent, high-quality work.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical trial tools.
Ability to work collaboratively in cross-functional teams.
Willingness to work shifts, if business needs require.
Work Environment
Role may involve extensive computer and keyboard usage.
Dynamic, fast-paced clinical research environment with exposure to global studies.
SEO & GEO Optimization Keywords
Centralized Study Specialist jobs Bangalore, Clinical Research jobs India, CRO jobs Bangalore, CTMS EDC eTMF roles, Clinical Trial Operations Specialist, Life Sciences jobs India, Fortrea clinical research careers.
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