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Senior Clinical Research Associate (Sr. Cra)

Syngene
Syngene
4-8 years
preferred by company
Bangalore, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Senior Clinical Research Associate (Sr. CRA)

Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Department: Clinical Operations / T&CR / Discovery Services
Company: Syngene
Experience Required: Senior Clinical Research Associate experience required (Typically 4–8+ years preferred)


Job Overview

An exciting opportunity is available for an experienced Senior Clinical Research Associate (Sr. CRA) within the clinical research and pharmaceutical development domain. This role is ideal for professionals with strong expertise in clinical trial monitoring, site management, GCP compliance, site initiation, patient recruitment oversight, regulatory documentation, and clinical operations execution.

The selected candidate will be responsible for managing clinical trial sites from site selection through close-out, ensuring protocol compliance, patient safety, data integrity, and operational excellence in accordance with global regulatory requirements.

This role is highly suited for professionals seeking advancement in clinical operations, site monitoring, pharmaceutical clinical research, CRO operations, and clinical trial management.


Key Responsibilities

Clinical Site Monitoring & Trial Execution

  • Conduct end-to-end site monitoring activities including:
    • Site selection visits
    • Site initiation visits
    • Routine monitoring visits
    • Site close-out visits
  • Ensure all study activities are conducted in compliance with:
    • Good Clinical Practice (GCP)
    • Study protocols
    • SOPs
    • Regulatory guidelines
    • Ethical requirements

Site Management & Study Oversight

  • Manage assigned study sites, protocols, and therapeutic programs
  • Serve as the primary operational contact for assigned clinical trial sites
  • Establish strong communication channels with investigators and site teams
  • Ensure site performance aligns with study timelines and quality expectations

Protocol Training & Site Enablement

  • Complete all required therapeutic area, protocol, SOP, and compliance training
  • Deliver protocol and study-related training to assigned site personnel
  • Support site readiness and operational compliance throughout study execution

Quality & Compliance Management

  • Ensure quality and integrity of study conduct at site level
  • Identify compliance issues, protocol deviations, and operational risks
  • Investigate quality concerns and collaborate with Clinical Project Managers for resolution
  • Support implementation of:
    • Corrective Actions (CAPA)
    • Preventive Actions
    • Site remediation plans

Regulatory & Ethics Oversight
Track and manage:

  • Regulatory submissions
  • Ethics Committee approvals
  • Site documentation compliance
  • Essential document completeness
  • Study startup and operational regulatory milestones

Ensure ongoing compliance with applicable clinical research regulations.

Patient Recruitment & Data Oversight
Monitor study progress through:

  • Subject recruitment tracking
  • Enrollment progress monitoring
  • Case Report Form (CRF) completion oversight
  • Data query generation and resolution follow-up
  • Site performance reviews

Ensure timely and accurate study execution.

Clinical Documentation Management
Create, maintain, and manage:

  • Monitoring visit reports
  • Follow-up letters
  • Site management documentation
  • Study records
  • Action plans
  • Compliance documentation

Ensure documentation accuracy, completeness, and audit readiness.

Operational Administration

  • Submit project timesheets and operational deliverables within required timelines
  • Support project-specific operational reporting and internal compliance processes

Safety & Quality Compliance

  • Maintain full compliance with:
    • EHS guidelines
    • Data integrity standards
    • Corporate quality systems
    • Workplace safety procedures
  • Support a culture of compliance, accountability, and operational excellence

Required Qualifications

Educational Qualifications
Candidates must hold one of the following:

  • M.Sc
  • M.Pharm
  • PharmD
  • BAMS
  • BDS
  • MDS
  • BHMS
  • Life Sciences degree