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TRDFIN Support Services Pvt Ltd
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Clinical Trial Specialist

Clinical Trial Specialist

TRDFIN Support Services Pvt Ltd

2 years

0 Lacs

bengaluru karnataka india

Posted:2 weeks ago| Platform:

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Skills Required

support planning management compliance documentation collaboration initiation monitoring gcp reporting audit inspection data query database communication capture excel word certifications research compensation collaborative

Work Mode

On-site

Job Type

Full Time

Job Description

Job Overview

Clinical Trial Specialist

Key Responsibilities

Support end-to-end
clinical trial operations
from study start up to close-out.
Coordinate with investigators, CROs, and study sites to ensure protocol adherence.
Prepare, maintain, and manage essential trial documentation and study files.
Assist with site initiation, monitoring, and close-out activities.
Track study timelines, milestones, and deliverables.
Ensure compliance with
ICH-GCP, SOPs, and regulatory requirements
.
Support IRB/EC submissions, amendments, and approvals.
Manage safety reporting, deviations, and issue tracking.
Assist in audit and inspection readiness.
Support data collection, query resolution, and database lock activities.

Required Skills & Qualifications

Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
2+ years of experience in
clinical trial operations or clinical research
.
Strong understanding of
clinical trial processes and ICH-GCP guidelines
.
Experience working with CROs, investigators, and clinical sites.
Strong documentation, organizational, and communication skills.
Ability to manage multiple studies and priorities effectively.
Attention to detail and strong compliance mindset.

Tools & Systems (Preferred)

Clinical Trial Management Systems (CTMS)
Electronic Trial Master File (eTMF) systems
Electronic Data Capture (EDC) systems
Microsoft Excel, Word, and PowerPoint

Certifications (Nice to Have)

ICH-GCP Certification
Clinical Research Coordinator (CRC) certification
Clinical Trial Management certifications

What We Offer

Competitive compensation and benefits
Exposure to global clinical trials and regulatory environments
Opportunities for career growth in clinical research and operations
Collaborative and compliance-focused work culture

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