Fortrea hiring Centralized Study Specialist I

Pharma Stuff; Bengaluru; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Fortrea is hiring a Centralized Study Specialist I in Bangalore to support day-to-day centralized study activities, ensure timely monitoring plan execution, and coordinate with clinical teams, CRAs, and vendors.

The role requires 3+ years of clinical research experience, familiarity with CTMS, IWRS, EDC, and eTMF, and a strong grasp of ICH-GCP and regulatory processes. It offers growth in centralized study operations within a global CRO environment.

Qualifications

• Minimum 3+ years of experience in clinical development, start-up, or regulatory processes.
• Experience in CRO, pharmaceutical, or healthcare settings.
• Familiarity with investigator start-up documents and contract or budget negotiation is an advantage.
• Working knowledge of ICH-GCP, IRB/IEC, Regulatory Affairs, and applicable guidelines.

Responsibilities

• Support day-to-day centralized study activities, ensuring timely execution of monitoring plans and accurate system maintenance.
• Coordinate between clinical teams, CRAs, and vendors to ensure study milestones are met.
• Maintain and manage CTMS, IWRS, EDC, and eTMF related documentation and quality control.
• Provide consolidated issue snapshots and assist in site visits and governance activities.

Skills

Clinical research experience

CRO exposure

Cross-functional coordination

Documentation management

Education

Life Sciences degree

Allied health certification considered

Tools

CTMS

IWRS

EDC

MS Project

eTMF

Job description

Centralized Study Specialist Vacancy Bangalore

Fortrea hiring Centralized Study Specialist I in Bangalore. 3+ years clinical research experience required.

URL Slug: fortrea-centralized-study-specialist

Fortrea is hiring a Centralized Study Specialist I for its Bangalore location. This full-time role is designed for experienced clinical research professionals who have strong exposure to centralized study operations, clinical trial systems, and cross-functional coordination. The position plays a critical role in supporting global clinical trials by ensuring high-quality study documentation, system compliance, and operational efficiency across the study lifecycle.

This opportunity is well suited for candidates who have worked in CRO or pharmaceutical environments and want to deepen their expertise in centralized monitoring, study management systems, and clinical trial governance.

Company Overview

Fortrea is a global contract research organization (CRO) providing end-to-end clinical development, pharmacovigilance, and regulatory solutions to pharmaceutical, biotechnology, and medical device companies. The organization supports clinical trials across multiple therapeutic areas and phases, with a strong focus on quality, compliance, and patient safety.

Fortrea operates in highly regulated environments and follows global standards such as ICH-GCP and applicable regulatory guidelines. Its centralized study and delivery teams play a key role in enabling efficient trial execution, data integrity, and regulatory readiness across global programs.

Job Role & Responsibilities

The Centralized Study Specialist I will support day-to-day centralized study activities, ensuring timely execution of monitoring plans, accurate system maintenance, and effective coordination between clinical teams, CRAs, and vendors.

Centralized Monitoring & Study Support

• Execute high-quality and timely centralized monitoring and reporting plans for approved protocols
• Support specialized monitoring requests as required by study management
• Track, analyze, and report study metrics within defined timelines
• Proactively identify process improvement opportunities and support implementation
• Mentor and train junior team members when required

Clinical Systems & Documentation Management

• Manage and maintain clinical trial systems including CTMS, IWRS, EDC, and other study databases
• Support eTMF management activities including document filing, tracking, and quality control
• Maintain Trial Master File documentation and participate in TMF QC and archival activities
• Document and track study activities using approved project management tools and systems

CRA and Site Coordination

• Track and follow up with CRAs for resolution of outstanding issues
• Prepare CRA Prep Packs and share them ahead of site visits
• Liaise with CRAs and clinical teams to resolve site-related queries and issues
• Provide consolidated issue snapshots to support effective and efficient site visits

Study Operations & Financial Support

• Assist in generating study-specific operational and compliance reports
• Support training compliance tracking for study teams
• Assist with site and vendor payment activities
• Support vendor management tasks including invoice tracking and PO requisitions

Project Governance & Advanced Support

• Update study timelines and milestones in MS Project, CTMS, and governance tools
• Escalate risks when timelines or deliverables are at risk
• Support project leads with study plans, coordination, and execution
• Initiate RIM changes, manage PCC logs, and support documentation impact tracking
• Handle PII assessments, system documentation, and XRIM updates
• Support implementation of Xcellerate Intelligence for Trial Efficiency (XITE) customizations
• Collaborate with functional leads to resolve system alerts and ensure project health

Eligibility / Qualifications

Educational Qualification

• University or College degree (Life Sciences preferred)
• Certification in allied health professions such as Nursing, Medical Technology, or Laboratory Technology may be considered
• Equivalent education or relevant experience may be accepted by Fortrea

Relevant courses include: BSc Life Sciences, BSc Biotechnology, BSc Microbiology, BPharm, MPharm, MSc Clinical Research, MSc Biotechnology, MSc Life Sciences, Nursing, Medical Laboratory Technology

Experience Requirements

• Minimum 3+ years of experience in clinical development, start-up, or regulatory processes
• Overall 5–8 years of relevant clinical research experience preferred
• Experience in CRO, pharmaceutical, or healthcare settings
• Familiarity with investigator start-up documents and contract or budget negotiation is an advantage
• Prior interaction with operational project teams and investigative sites preferred

Regulatory Knowledge & Skills

• Working knowledge of ICH-GCP, IRB/IEC, Regulatory Affairs, and applicable guidelines
• Understanding of the clinical trial process and lifecycle
• Strong organizational, communication, and time management skills
• High attention to detail and ability to deliver consistent, high-quality work
• Proficiency in MS Office tools including Word, Excel, and PowerPoint

Location & Salary

• Job Location: Bangalore, India
• Employment Type: Full-time
• Work Model: Office-based / hybrid based on project needs

FAQs – Centralized Study Specialist I

Who can apply for this role?

Candidates with a life sciences degree and at least 3 years of clinical research experience are eligible.

Is this role suitable for freshers?

No. This role requires prior clinical research or CRO experience.

What systems will I work with?

You will work with CTMS, IWRS, EDC, eTMF, MS Project, and other clinical trial systems.

Does the role involve leadership responsibilities?

Yes. The role includes mentoring, coordination, and leadership support for study teams.

What are the career growth opportunities?

This role provides a pathway to senior centralized study roles, project management, and clinical operations leadership.