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Senior Clinical Trial Associate

2+ years
₹6–9 LPA
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Trial Associate
Location: India (Remote or Office-Based)
Company: Catalyst Clinical Research


Job Summary:
Catalyst Clinical Research is seeking a Senior Clinical Trial Associate (CTA) to support its global clinical operations, focusing on administrative, documentation, and coordination tasks for both internal teams and external clients. As part of a customer-centric, flexible service model, the CTA will ensure adherence to ICH-GCP, SOPs, and regulatory requirements to maintain high-quality trial conduct and subject safety across oncology and multi-therapeutic trials.


Key Responsibilities:

  • Support clinical trial operations in terms of time, cost, and quality, following ICH-GCP, SOPs, and regulations

  • Set up and maintain Trial Master Files (TMFs) and documentation folders in compliance with the DIA reference model

  • Coordinate the collection of essential documents during site initiation and setup

  • Assist project managers in study reports, updates, and documentation tasks

  • Schedule and document trial-specific meetings, track screening/enrollment across sites

  • Manage investigator site payments and ensure timely tracking and reconciliation

  • Coordinate clinical trial supplies, including logistics and shipment of materials (e.g., lab kits, manuals, protocols)

  • Prepare and distribute Clinical Trial documents like Investigator Brochures and Site Files

  • Update trial tracking systems for IP management, monitoring visits, payments, etc.

  • Act as a liaison for sites, maintaining effective communication and document management

  • Build and maintain strong relationships with investigators and study staff

  • Support internal corporate administration activities as needed


Required Qualifications:

  • Bachelor’s degree or equivalent in Life Sciences or Nursing


Experience:

  • Minimum 2 years of experience in clinical trials, preferably in pharma, CRO, or NHS environments

  • Experience maintaining TMFs and ISFs per ICH-GCP and DIA reference model


Required Skills:

  • Solid understanding of ICH-GCP and regulatory requirements

  • Strong documentation and file management skills

  • Proficiency in Microsoft PowerPoint, Excel, and Word

  • Excellent verbal/written communication and interpersonal skills

  • Strong organizational and time management capabilities

  • Ability to multi-task, work independently, and collaborate across teams

  • Willingness to travel domestically/internationally as needed

  • Ability to manage conflicts and influence internal/external stakeholders effectively


Working Conditions:

  • Sedentary work involving prolonged sitting or standing

  • May be office-based or remote, depending on candidate location and team needs


Estimated Salary: ₹6–9 LPA (based on clinical trial support roles in mid-senior positions within Indian CRO/pharma industry)